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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

MACRA is now a fact of life.

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



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



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

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

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

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

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

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



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



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

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

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



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



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

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

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

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

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

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



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



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

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

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

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

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

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

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

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



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



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

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

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

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



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



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

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

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

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

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

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

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

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

[email protected]

MACRA is now a fact of life.

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



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



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

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

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

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

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

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



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



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

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

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



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



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

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

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

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

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

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



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



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

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

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

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

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

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

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

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



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



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

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

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

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



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



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

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

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

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

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

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

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

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

[email protected]

MACRA is now a fact of life.

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



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



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

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

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

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

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

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



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



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

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

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



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



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

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

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

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

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

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



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



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

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

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

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

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

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

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

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



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



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

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

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

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



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



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

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

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

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

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

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

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

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

[email protected]

ATLANTA – Results from a large cross-sectional survey of adults who meet diagnostic symptom criteria for chronic rhinosinusitis (CRS) reveal that most report suffering significant symptoms, high rates of physician visits, and dissatisfaction with current intranasal steroid sprays.

“Chronic rhinosinusitis is common, it’s severe, and people are seeking a lot of medical care,” study author Ramy A. Mahmoud, MD, said in an interview at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “It’s causing a lot of disruption in their lives, and they’re not satisfied with currently available intranasal steroids.”

[email protected]

ATLANTA – Results from a large cross-sectional survey of adults who meet diagnostic symptom criteria for chronic rhinosinusitis (CRS) reveal that most report suffering significant symptoms, high rates of physician visits, and dissatisfaction with current intranasal steroid sprays.

“Chronic rhinosinusitis is common, it’s severe, and people are seeking a lot of medical care,” study author Ramy A. Mahmoud, MD, said in an interview at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “It’s causing a lot of disruption in their lives, and they’re not satisfied with currently available intranasal steroids.”

[email protected]

ATLANTA – Results from a large cross-sectional survey of adults who meet diagnostic symptom criteria for chronic rhinosinusitis (CRS) reveal that most report suffering significant symptoms, high rates of physician visits, and dissatisfaction with current intranasal steroid sprays.

“Chronic rhinosinusitis is common, it’s severe, and people are seeking a lot of medical care,” study author Ramy A. Mahmoud, MD, said in an interview at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “It’s causing a lot of disruption in their lives, and they’re not satisfied with currently available intranasal steroids.”

[email protected]

Psychological factors, rather than disease activity, were significantly associated with symptoms in children and teens with Crohn’s disease, based on data from 127 children aged 8-18 years.

Patients completed questionnaires on symptom severity and disability, as well as psychological measures assessing anxiety, depression, pain beliefs, and coping. Disease activity was measured by the Pediatric Crohn’s Disease Activity Index.

The researchers used a model to assess how psychology factors and disease activity impacted symptoms and disability.

The disability model showed significant associations with both psychological factors (P less than .001) and disease activity (P less than .05). However, the symptoms model showed a significant association only with psychological factors (P less than .001).

“One possible explanation for our findings is that many patients with Crohn’s disease report elevated levels of psychological distress,” wrote Miranda A. L. van Tilburg, PhD, of the University of North Carolina at Chapel Hill and colleagues.

Although the study was limited by the use of self-reports, “this finding is an important one because symptom presentation often plays an important role in treatment decisions, which could lead to unnecessary exposure to tests and treatments, with potential negative side effects,” the researchers wrote. “When confronted with a pediatric patient with Crohn’s disease who has high levels of psychological distress, independent of his or her inflammatory status, the clinician should consider incorporating behavioral techniques such as education, reassurance, and cognitive behavior therapy into the management plan,” they said.

The researchers had no financial conflicts to disclose.

Read the full study here: doi: 10.1016/j.jpeds.2017.01.058.

Psychological factors, rather than disease activity, were significantly associated with symptoms in children and teens with Crohn’s disease, based on data from 127 children aged 8-18 years.

Patients completed questionnaires on symptom severity and disability, as well as psychological measures assessing anxiety, depression, pain beliefs, and coping. Disease activity was measured by the Pediatric Crohn’s Disease Activity Index.

The researchers used a model to assess how psychology factors and disease activity impacted symptoms and disability.

The disability model showed significant associations with both psychological factors (P less than .001) and disease activity (P less than .05). However, the symptoms model showed a significant association only with psychological factors (P less than .001).

“One possible explanation for our findings is that many patients with Crohn’s disease report elevated levels of psychological distress,” wrote Miranda A. L. van Tilburg, PhD, of the University of North Carolina at Chapel Hill and colleagues.

Although the study was limited by the use of self-reports, “this finding is an important one because symptom presentation often plays an important role in treatment decisions, which could lead to unnecessary exposure to tests and treatments, with potential negative side effects,” the researchers wrote. “When confronted with a pediatric patient with Crohn’s disease who has high levels of psychological distress, independent of his or her inflammatory status, the clinician should consider incorporating behavioral techniques such as education, reassurance, and cognitive behavior therapy into the management plan,” they said.

The researchers had no financial conflicts to disclose.

Read the full study here: doi: 10.1016/j.jpeds.2017.01.058.

Psychological factors, rather than disease activity, were significantly associated with symptoms in children and teens with Crohn’s disease, based on data from 127 children aged 8-18 years.

Patients completed questionnaires on symptom severity and disability, as well as psychological measures assessing anxiety, depression, pain beliefs, and coping. Disease activity was measured by the Pediatric Crohn’s Disease Activity Index.

The researchers used a model to assess how psychology factors and disease activity impacted symptoms and disability.

The disability model showed significant associations with both psychological factors (P less than .001) and disease activity (P less than .05). However, the symptoms model showed a significant association only with psychological factors (P less than .001).

“One possible explanation for our findings is that many patients with Crohn’s disease report elevated levels of psychological distress,” wrote Miranda A. L. van Tilburg, PhD, of the University of North Carolina at Chapel Hill and colleagues.

Although the study was limited by the use of self-reports, “this finding is an important one because symptom presentation often plays an important role in treatment decisions, which could lead to unnecessary exposure to tests and treatments, with potential negative side effects,” the researchers wrote. “When confronted with a pediatric patient with Crohn’s disease who has high levels of psychological distress, independent of his or her inflammatory status, the clinician should consider incorporating behavioral techniques such as education, reassurance, and cognitive behavior therapy into the management plan,” they said.

The researchers had no financial conflicts to disclose.

Read the full study here: doi: 10.1016/j.jpeds.2017.01.058.

The influenza vaccine is underused in children with heart disease; approximately one-third were vaccinated in a prospective study of 186 children in September and October 2012.

“Annual influenza vaccination is the most effective and safe means of preventing the disease,” and children with chronic diseases including heart conditions are at increased risk for complications that would require hospitalization, wrote Gilat Livni, MD, of Tel Aviv University and colleagues.

Choreograph/Thinkstock

The influenza vaccine is underused in children with heart disease; approximately one-third were vaccinated in a prospective study of 186 children in September and October 2012.

“Annual influenza vaccination is the most effective and safe means of preventing the disease,” and children with chronic diseases including heart conditions are at increased risk for complications that would require hospitalization, wrote Gilat Livni, MD, of Tel Aviv University and colleagues.

Choreograph/Thinkstock

The influenza vaccine is underused in children with heart disease; approximately one-third were vaccinated in a prospective study of 186 children in September and October 2012.

“Annual influenza vaccination is the most effective and safe means of preventing the disease,” and children with chronic diseases including heart conditions are at increased risk for complications that would require hospitalization, wrote Gilat Livni, MD, of Tel Aviv University and colleagues.

Choreograph/Thinkstock

WASHINGTON – Subclinical leaflet thrombosis, as evidenced by reduced leaflet motion and corresponding hypoattenuating lesions on high-resolution CT, occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically, according to a report presented at the annual meeting of the American College of Cardiology and simultaneously published March 19 in the Lancet.

In an observational cohort study involving 890 patients enrolled in two single-center registries, reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%) by four-dimensional, volume-rendered CT. The thrombosis was hemodynamically silent and undetected by transthoracic echocardiograms done in a large subgroup of the study participants. Mean aortic valve gradients were numerically higher in affected patients, but still fell within the normal range in most of them, said Raj R. Makkar, MD, of Cedars-Sinai Heart Institute, Los Angeles.

Mitchel L. Zoler contributed to this report.

Correction, 3/20/17: An earlier version of this article misstated the clinical evidence for possible leaflet thrombosis on a replaced aortic valve.

WASHINGTON – Subclinical leaflet thrombosis, as evidenced by reduced leaflet motion and corresponding hypoattenuating lesions on high-resolution CT, occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically, according to a report presented at the annual meeting of the American College of Cardiology and simultaneously published March 19 in the Lancet.

In an observational cohort study involving 890 patients enrolled in two single-center registries, reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%) by four-dimensional, volume-rendered CT. The thrombosis was hemodynamically silent and undetected by transthoracic echocardiograms done in a large subgroup of the study participants. Mean aortic valve gradients were numerically higher in affected patients, but still fell within the normal range in most of them, said Raj R. Makkar, MD, of Cedars-Sinai Heart Institute, Los Angeles.

Mitchel L. Zoler contributed to this report.

Correction, 3/20/17: An earlier version of this article misstated the clinical evidence for possible leaflet thrombosis on a replaced aortic valve.

WASHINGTON – Subclinical leaflet thrombosis, as evidenced by reduced leaflet motion and corresponding hypoattenuating lesions on high-resolution CT, occurs frequently in bioprosthetic aortic valves implanted either by the transcatheter route or surgically, according to a report presented at the annual meeting of the American College of Cardiology and simultaneously published March 19 in the Lancet.

In an observational cohort study involving 890 patients enrolled in two single-center registries, reduced leaflet motion signaling the presence of thrombosis was detected in 106 patients (12%) by four-dimensional, volume-rendered CT. The thrombosis was hemodynamically silent and undetected by transthoracic echocardiograms done in a large subgroup of the study participants. Mean aortic valve gradients were numerically higher in affected patients, but still fell within the normal range in most of them, said Raj R. Makkar, MD, of Cedars-Sinai Heart Institute, Los Angeles.

Mitchel L. Zoler contributed to this report.

Correction, 3/20/17: An earlier version of this article misstated the clinical evidence for possible leaflet thrombosis on a replaced aortic valve.

WASHINGTON – Concerns about possible adverse cognitive effects from the new lipid-lowering drug evolocumab and from aggressive lowering of LDL cholesterol were largely put to rest with results from a nearly 2,000-patient study showing that a median 20 months of treatment with evolocumab caused no cognitive or memory decline, either compared with baseline measures or compared with similar patients randomized to placebo treatment.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]
On Twitter @mitchelzoler

WASHINGTON – Concerns about possible adverse cognitive effects from the new lipid-lowering drug evolocumab and from aggressive lowering of LDL cholesterol were largely put to rest with results from a nearly 2,000-patient study showing that a median 20 months of treatment with evolocumab caused no cognitive or memory decline, either compared with baseline measures or compared with similar patients randomized to placebo treatment.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]
On Twitter @mitchelzoler

WASHINGTON – Concerns about possible adverse cognitive effects from the new lipid-lowering drug evolocumab and from aggressive lowering of LDL cholesterol were largely put to rest with results from a nearly 2,000-patient study showing that a median 20 months of treatment with evolocumab caused no cognitive or memory decline, either compared with baseline measures or compared with similar patients randomized to placebo treatment.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]
On Twitter @mitchelzoler

WASHINGTON – Instantaneous wave-free ratio (iFR) is the new evidence-based standard of care for invasive physiologic assessment of stable coronary lesions of intermediate angiographic severity, supplanting the older fractional flow reserve (FFR) technology, Matthias Gotberg, MD, said at the annual meeting of the American College of Cardiology.

He presented the potentially game-changing findings of the iFR-SWEDEHEART trial, one of two large randomized trials of iFR versus FFR presented at the conference, the other being the DEFINE-FLAIR study.

The virtually identical results of these two trials should encourage more interventional cardiologists to incorporate physiologic assessment of stable coronary lesions into their clinical practice instead of relying solely on anatomic assessment by angiography, which abundant evidence shows is insufficiently accurate in identifying hemodynamically significant lesions warranting revascularization.

FFR never really caught on because of its limitations. DEFINE-FLAIR and iFR-SWEDEHEART show that iFR overcomes those limitations, said Dr. Gotberg, director of the cardiac catheterization laboratory at Skane University Hospital in Lund, Sweden.

The two studies showed that iFR was noninferior to FFR in the 1-year composite endpoint of all-cause mortality, nonfatal MI, or unplanned revascularization. And iFR was associated with significantly shorter procedure times, less stent utilization, and markedly less patient discomfort because, unlike FFR, it doesn’t require administration of adenosine to induce hyperemia.

Indeed, in iFR-SWEDEHEART, which included more than 2,000 randomized patients in three Scandinavian countries, only 3% of the iFR group reported experiencing chest pain, dyspnea, or other forms of discomfort during their procedure, compared with 68% of the FFR group, Dr. Gotberg explains in this video interview.[[{"fid":"192539","view_mode":"medstat_image_full_text","attributes":{"height":"390","width":"100%","class":"media-element file-medstat-image-full-text","data-delta":"1"},"fields":{"format":"medstat_image_full_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_full_text"}}}]]

[email protected]

WASHINGTON – Instantaneous wave-free ratio (iFR) is the new evidence-based standard of care for invasive physiologic assessment of stable coronary lesions of intermediate angiographic severity, supplanting the older fractional flow reserve (FFR) technology, Matthias Gotberg, MD, said at the annual meeting of the American College of Cardiology.

He presented the potentially game-changing findings of the iFR-SWEDEHEART trial, one of two large randomized trials of iFR versus FFR presented at the conference, the other being the DEFINE-FLAIR study.

The virtually identical results of these two trials should encourage more interventional cardiologists to incorporate physiologic assessment of stable coronary lesions into their clinical practice instead of relying solely on anatomic assessment by angiography, which abundant evidence shows is insufficiently accurate in identifying hemodynamically significant lesions warranting revascularization.

FFR never really caught on because of its limitations. DEFINE-FLAIR and iFR-SWEDEHEART show that iFR overcomes those limitations, said Dr. Gotberg, director of the cardiac catheterization laboratory at Skane University Hospital in Lund, Sweden.

The two studies showed that iFR was noninferior to FFR in the 1-year composite endpoint of all-cause mortality, nonfatal MI, or unplanned revascularization. And iFR was associated with significantly shorter procedure times, less stent utilization, and markedly less patient discomfort because, unlike FFR, it doesn’t require administration of adenosine to induce hyperemia.

Indeed, in iFR-SWEDEHEART, which included more than 2,000 randomized patients in three Scandinavian countries, only 3% of the iFR group reported experiencing chest pain, dyspnea, or other forms of discomfort during their procedure, compared with 68% of the FFR group, Dr. Gotberg explains in this video interview.[[{"fid":"192539","view_mode":"medstat_image_full_text","attributes":{"height":"390","width":"100%","class":"media-element file-medstat-image-full-text","data-delta":"1"},"fields":{"format":"medstat_image_full_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_full_text"}}}]]

[email protected]

WASHINGTON – Instantaneous wave-free ratio (iFR) is the new evidence-based standard of care for invasive physiologic assessment of stable coronary lesions of intermediate angiographic severity, supplanting the older fractional flow reserve (FFR) technology, Matthias Gotberg, MD, said at the annual meeting of the American College of Cardiology.

He presented the potentially game-changing findings of the iFR-SWEDEHEART trial, one of two large randomized trials of iFR versus FFR presented at the conference, the other being the DEFINE-FLAIR study.

The virtually identical results of these two trials should encourage more interventional cardiologists to incorporate physiologic assessment of stable coronary lesions into their clinical practice instead of relying solely on anatomic assessment by angiography, which abundant evidence shows is insufficiently accurate in identifying hemodynamically significant lesions warranting revascularization.

FFR never really caught on because of its limitations. DEFINE-FLAIR and iFR-SWEDEHEART show that iFR overcomes those limitations, said Dr. Gotberg, director of the cardiac catheterization laboratory at Skane University Hospital in Lund, Sweden.

The two studies showed that iFR was noninferior to FFR in the 1-year composite endpoint of all-cause mortality, nonfatal MI, or unplanned revascularization. And iFR was associated with significantly shorter procedure times, less stent utilization, and markedly less patient discomfort because, unlike FFR, it doesn’t require administration of adenosine to induce hyperemia.

Indeed, in iFR-SWEDEHEART, which included more than 2,000 randomized patients in three Scandinavian countries, only 3% of the iFR group reported experiencing chest pain, dyspnea, or other forms of discomfort during their procedure, compared with 68% of the FFR group, Dr. Gotberg explains in this video interview.[[{"fid":"192539","view_mode":"medstat_image_full_text","attributes":{"height":"390","width":"100%","class":"media-element file-medstat-image-full-text","data-delta":"1"},"fields":{"format":"medstat_image_full_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_full_text"}}}]]

[email protected]

SEATTLE – Improvements in diagnosis and treatment have lengthened the survival time of patients with colorectal cancer, but the majority of deaths from CRC occur within the first 5 years.

According to new findings presented at the annual Society of Surgical Oncology Cancer Symposium, CRC as a cause of death is surpassed by cardiovascular disease (CVD) and second primary cancers as time goes on.

Courtesy Wikimedia Commons/nephron/Creative Commons License

SEATTLE – Improvements in diagnosis and treatment have lengthened the survival time of patients with colorectal cancer, but the majority of deaths from CRC occur within the first 5 years.

According to new findings presented at the annual Society of Surgical Oncology Cancer Symposium, CRC as a cause of death is surpassed by cardiovascular disease (CVD) and second primary cancers as time goes on.

Courtesy Wikimedia Commons/nephron/Creative Commons License

SEATTLE – Improvements in diagnosis and treatment have lengthened the survival time of patients with colorectal cancer, but the majority of deaths from CRC occur within the first 5 years.

According to new findings presented at the annual Society of Surgical Oncology Cancer Symposium, CRC as a cause of death is surpassed by cardiovascular disease (CVD) and second primary cancers as time goes on.

Courtesy Wikimedia Commons/nephron/Creative Commons License

Photo by Sage Ross

WASHINGTON, DC—Results of a phase 2 trial suggest rivaroxaban and aspirin have similar safety profiles in patients with acute coronary syndrome (ACS) who are also taking a P2Y12 inhibitor.

Researchers found that, overall, the risk of bleeding was similar whether patients received aspirin or rivaroxaban.

There was no significant difference between the groups when the researchers used TIMI, GUSTO, or BARC bleeding definitions.

However, patients who received rivaroxaban did have a significantly increased risk of bleeding according to the ISTH major bleeding definition.

There was no significant difference between the treatment groups when it came to the study’s efficacy endpoints, although the researchers said the study was not adequately powered to assess efficacy.

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

The study, known as GEMINI-ACS-1, was funded by Janssen Research & Development and Bayer AG.

In this trial, researchers compared rivaroxaban (given at 2.5 mg twice daily) and aspirin (at 100 mg once daily) in patients with ACS who were also receiving clopidogrel or ticagrelor for the secondary prevention of cardiovascular events.

The trial included 3037 adults with unstable angina, non-ST segment elevation myocardial infarction, or ST segment elevation myocardial infarction. Patients had positive cardiac biomarkers and either ischemic electrocardiographic changes or an atherosclerotic culprit lesion identified during angiography.

Within 10 days of hospital admission for ACS, the patients were randomized to receive aspirin (n=1518) or rivaroxaban (n=1519). Patients also received clopidogrel (n=1333) or ticagrelor (n=1704) based on investigator preference.

Patients received a minimum of 180 days of study treatment. The median treatment duration was 291 days.

Safety

The study’s primary endpoint was TIMI clinically significant bleeding not related to coronary artery bypass grafting (CABG) up to day 390.

This type of bleeding occurred in 5.3% of patients in the rivaroxaban group and 4.9% of patients in the aspirin group. The hazard ratio (HR) was 1.09 (P=0.5840).

The researchers also assessed other types of bleeding and used other bleeding definitions. The HRs for these endpoints (with aspirin as the reference) were as follows.

• TIMI major bleeding, HR=1.25 (P=0.6341)
• TIMI non-CABG major bleeding, HR=1.25 (P=0.6341)
• TIMI minor bleeding, HR=2.25 (P=0.1664)
• TIMI bleeding requiring medical attention, HR=1.01 (P=0.9581)
• TIMI insignificant bleeding, HR=0.84 (P=0.5504)

• GUSTO life-threatening or severe bleeding, HR=1.50 (P=0.6571)
• GUSTO life-threatening, severe, or moderate bleeding, HR=1.58 (P=0.3395)
• GUSTO life-threatening, severe, moderate, or mild bleeding, HR=1.04 (P=0.7869)

• BARC 3a and higher bleeding, HR=1.70 (P=0.1263)
• BARC 3b and higher bleeding, HR=1.38 (P=0.4882)

• ISTH major bleeding, HR=1.83 (P=0.0420)

Efficacy

Researchers also examined several exploratory efficacy endpoints. For the composite efficacy endpoint (which included cardiovascular death, myocardial infarction, stroke, and stent thrombosis), the 2 treatment groups had similar rates.

Five percent of patients in the rivaroxaban group and 4.7% of patients in the aspirin group experienced one of these cardiovascular events. The HR was 1.06 (P=0.7316).

There was no significant difference between the treatment arms for the individual components of the efficacy endpoint or for all-cause death.

The HRs were 1.12 (P=0.7401) for cardiovascular death, 1.15 (P=0.4872) for myocardial infarction, 0.58 (P=0.2506) for stroke, 1.37 (P=0.4917) for definite stent thrombosis, and 0.95 (P=0.8771) for all-cause death.  

Photo by Sage Ross

WASHINGTON, DC—Results of a phase 2 trial suggest rivaroxaban and aspirin have similar safety profiles in patients with acute coronary syndrome (ACS) who are also taking a P2Y12 inhibitor.

Researchers found that, overall, the risk of bleeding was similar whether patients received aspirin or rivaroxaban.

There was no significant difference between the groups when the researchers used TIMI, GUSTO, or BARC bleeding definitions.

However, patients who received rivaroxaban did have a significantly increased risk of bleeding according to the ISTH major bleeding definition.

There was no significant difference between the treatment groups when it came to the study’s efficacy endpoints, although the researchers said the study was not adequately powered to assess efficacy.

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

The study, known as GEMINI-ACS-1, was funded by Janssen Research & Development and Bayer AG.

In this trial, researchers compared rivaroxaban (given at 2.5 mg twice daily) and aspirin (at 100 mg once daily) in patients with ACS who were also receiving clopidogrel or ticagrelor for the secondary prevention of cardiovascular events.

The trial included 3037 adults with unstable angina, non-ST segment elevation myocardial infarction, or ST segment elevation myocardial infarction. Patients had positive cardiac biomarkers and either ischemic electrocardiographic changes or an atherosclerotic culprit lesion identified during angiography.

Within 10 days of hospital admission for ACS, the patients were randomized to receive aspirin (n=1518) or rivaroxaban (n=1519). Patients also received clopidogrel (n=1333) or ticagrelor (n=1704) based on investigator preference.

Patients received a minimum of 180 days of study treatment. The median treatment duration was 291 days.

Safety

The study’s primary endpoint was TIMI clinically significant bleeding not related to coronary artery bypass grafting (CABG) up to day 390.

This type of bleeding occurred in 5.3% of patients in the rivaroxaban group and 4.9% of patients in the aspirin group. The hazard ratio (HR) was 1.09 (P=0.5840).

The researchers also assessed other types of bleeding and used other bleeding definitions. The HRs for these endpoints (with aspirin as the reference) were as follows.

• TIMI major bleeding, HR=1.25 (P=0.6341)
• TIMI non-CABG major bleeding, HR=1.25 (P=0.6341)
• TIMI minor bleeding, HR=2.25 (P=0.1664)
• TIMI bleeding requiring medical attention, HR=1.01 (P=0.9581)
• TIMI insignificant bleeding, HR=0.84 (P=0.5504)

• GUSTO life-threatening or severe bleeding, HR=1.50 (P=0.6571)
• GUSTO life-threatening, severe, or moderate bleeding, HR=1.58 (P=0.3395)
• GUSTO life-threatening, severe, moderate, or mild bleeding, HR=1.04 (P=0.7869)

• BARC 3a and higher bleeding, HR=1.70 (P=0.1263)
• BARC 3b and higher bleeding, HR=1.38 (P=0.4882)

• ISTH major bleeding, HR=1.83 (P=0.0420)

Efficacy

Researchers also examined several exploratory efficacy endpoints. For the composite efficacy endpoint (which included cardiovascular death, myocardial infarction, stroke, and stent thrombosis), the 2 treatment groups had similar rates.

Five percent of patients in the rivaroxaban group and 4.7% of patients in the aspirin group experienced one of these cardiovascular events. The HR was 1.06 (P=0.7316).

There was no significant difference between the treatment arms for the individual components of the efficacy endpoint or for all-cause death.

The HRs were 1.12 (P=0.7401) for cardiovascular death, 1.15 (P=0.4872) for myocardial infarction, 0.58 (P=0.2506) for stroke, 1.37 (P=0.4917) for definite stent thrombosis, and 0.95 (P=0.8771) for all-cause death.  

Photo by Sage Ross

WASHINGTON, DC—Results of a phase 2 trial suggest rivaroxaban and aspirin have similar safety profiles in patients with acute coronary syndrome (ACS) who are also taking a P2Y12 inhibitor.

Researchers found that, overall, the risk of bleeding was similar whether patients received aspirin or rivaroxaban.

There was no significant difference between the groups when the researchers used TIMI, GUSTO, or BARC bleeding definitions.

However, patients who received rivaroxaban did have a significantly increased risk of bleeding according to the ISTH major bleeding definition.

There was no significant difference between the treatment groups when it came to the study’s efficacy endpoints, although the researchers said the study was not adequately powered to assess efficacy.

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

The study, known as GEMINI-ACS-1, was funded by Janssen Research & Development and Bayer AG.

In this trial, researchers compared rivaroxaban (given at 2.5 mg twice daily) and aspirin (at 100 mg once daily) in patients with ACS who were also receiving clopidogrel or ticagrelor for the secondary prevention of cardiovascular events.

The trial included 3037 adults with unstable angina, non-ST segment elevation myocardial infarction, or ST segment elevation myocardial infarction. Patients had positive cardiac biomarkers and either ischemic electrocardiographic changes or an atherosclerotic culprit lesion identified during angiography.

Within 10 days of hospital admission for ACS, the patients were randomized to receive aspirin (n=1518) or rivaroxaban (n=1519). Patients also received clopidogrel (n=1333) or ticagrelor (n=1704) based on investigator preference.

Patients received a minimum of 180 days of study treatment. The median treatment duration was 291 days.

Safety

The study’s primary endpoint was TIMI clinically significant bleeding not related to coronary artery bypass grafting (CABG) up to day 390.

This type of bleeding occurred in 5.3% of patients in the rivaroxaban group and 4.9% of patients in the aspirin group. The hazard ratio (HR) was 1.09 (P=0.5840).

The researchers also assessed other types of bleeding and used other bleeding definitions. The HRs for these endpoints (with aspirin as the reference) were as follows.

• TIMI major bleeding, HR=1.25 (P=0.6341)
• TIMI non-CABG major bleeding, HR=1.25 (P=0.6341)
• TIMI minor bleeding, HR=2.25 (P=0.1664)
• TIMI bleeding requiring medical attention, HR=1.01 (P=0.9581)
• TIMI insignificant bleeding, HR=0.84 (P=0.5504)

• GUSTO life-threatening or severe bleeding, HR=1.50 (P=0.6571)
• GUSTO life-threatening, severe, or moderate bleeding, HR=1.58 (P=0.3395)
• GUSTO life-threatening, severe, moderate, or mild bleeding, HR=1.04 (P=0.7869)

• BARC 3a and higher bleeding, HR=1.70 (P=0.1263)
• BARC 3b and higher bleeding, HR=1.38 (P=0.4882)

• ISTH major bleeding, HR=1.83 (P=0.0420)

Efficacy

Researchers also examined several exploratory efficacy endpoints. For the composite efficacy endpoint (which included cardiovascular death, myocardial infarction, stroke, and stent thrombosis), the 2 treatment groups had similar rates.

Five percent of patients in the rivaroxaban group and 4.7% of patients in the aspirin group experienced one of these cardiovascular events. The HR was 1.06 (P=0.7316).

There was no significant difference between the treatment arms for the individual components of the efficacy endpoint or for all-cause death.

The HRs were 1.12 (P=0.7401) for cardiovascular death, 1.15 (P=0.4872) for myocardial infarction, 0.58 (P=0.2506) for stroke, 1.37 (P=0.4917) for definite stent thrombosis, and 0.95 (P=0.8771) for all-cause death.