ACS Surgery News

On Oct. 6, after many months of anticipation, the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health IT published the 2015 Meaningful Use final rule. This long-awaited document, weighing in at almost 800 pages, contains some major changes to the Meaningful Use program beginning this year. By the time you read this, you’ll no doubt have heard about the major aspects of the changes. Regardless, we thought it would be useful to focus our lens on the new rules and consider how they will translate from the legislature into the real world.

What’s new?

Contrary to its name, the electronic health record incentive program has been considered hardly “meaningful” by physicians struggling to meet the objectives. Up to this point, it’s seemingly been more about busywork and aimless button-clicking than meaningful work. The 2015 final rule seeks to finally change that. In the press release accompanying the announcement, Dr. Patrick Conway, CMS Deputy Administrator, offered the following:

“We have a shared goal of electronic health records helping physicians, clinicians, and hospitals to deliver better care, smarter spending, and healthier people. We eliminated unnecessary requirements, simplified and increased flexibility for those that remain, and focused on interoperability, information exchange, and patient engagement.”

Expanding on his comments, we’ll first point out the change in length of the meaningful use reporting period. In 2015, it has been shortened to 90 days, regardless of stage. For most, this will elicit a huge sigh of relief, as providers now have the option to choose any continuous 90-day period within 2015 instead of being forced to report for the full year. This fundamental change adds tremendous flexibility to the program, as it eliminates the do-or-die scenario of full-year reporting and allows providers to retrospectively select an optimal attestation period.

Next is the streamlining of the required measures. From 20 measures, the list has been brought down to 10: 9 core objectives and 1 public health objective. In doing this, the CMS sought to remove the “checkbox processes” that have become a much-maligned hallmark of meaningful use. The agency also made an attempt to remove measures considered redundant, duplicative, or topped-out (such as demographic and vital sign documentation). Finally, the CMS essentially removed the core and menu structure and consolidated all measures, so that all providers are working off the same playbook, regardless of stage.

Third, and perhaps most interestingly, is the focus of the remaining objectives. As Dr. Conway related, the measures that the CMS has chosen to retain aim very clearly at a few key goals, with data-sharing principal among them. In fact, more than half the measures rely on information exchange. CMS has admitted that efforts thus far have not produced the kind of transformational interoperability intended, but that ultimately this is the direction EHRs need to take if they are to fulfill their true promise. Although we tend to agree (and we will be writing in greater detail about this in future columns), we feel it’s important to note that this will continue to be challenging for providers and vendors. Until data standards are universally adopted by EHR vendors, health care providers will be forced to bear the burden of imperfect interoperability.

Fortunately, one area in which the burden on physicians has been lightened is patient participation in meaningful use. The CMS has realized the impracticality of measures that rely completely on patients for success and removed the compliance thresholds for secure electronic messages and electronic portal usage. These tools need to be made available to patients, but providers are no longer held responsible for whether or not a certain percentage of patients choose to use them. In 2015, only one patient needs to “view, download, or transmit” information through a patient portal, and secure email capability only needs to be enabled, even if no one opts to use it.

Finally, the CMS is clear to point out that it sympathizes with those who have been unsuccessful in attaining meaningful use, encouraging them to submit requests for hardship exceptions “through the existing request process.” Unfortunately, this process is fairly narrow in scope and really only applies in cases of vendor delays or significant unforeseen consequences (such as bankruptcy, fire, or natural disasters). Still, there is no penalty in applying for an exception even if it is not granted, so, while CMS plans to grant only a limited number of exceptions, we would echo the encouragement to apply if needed.

What’s next?

The 2015 final rule is yet another step in laying groundwork for Meaningful Use stage III, which will be optional in 2017 and mandatory in 2018. The delay offers providers and vendors additional time to adapt and comply with the new regulations, while hopefully adding simplicity and flexibility to the process. Ultimately, this also better aligns reporting Meaningful Use with other incentive programs, all of which will be eventually consolidated under MIPS, the Merit-based Incentive Payment System (we’ll have more on this in a later column, but we want you to know that it is a new system of value-based reimbursement that will sunset the Meaningful Use payment adjustment at the end of calendar year 2018).

We applaud the efforts taken by CMS and the Office of the National Coordinator for Health IT to further streamline the Meaningful Use program and agree with their intent. According to the press release, they have attempted to “shift the paradigm so health IT becomes a tool for care improvement, not an end in itself.” We firmly believe in this idea, and are ultimately encouraged by the 2015 final rule.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

On Oct. 6, after many months of anticipation, the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health IT published the 2015 Meaningful Use final rule. This long-awaited document, weighing in at almost 800 pages, contains some major changes to the Meaningful Use program beginning this year. By the time you read this, you’ll no doubt have heard about the major aspects of the changes. Regardless, we thought it would be useful to focus our lens on the new rules and consider how they will translate from the legislature into the real world.

What’s new?

Contrary to its name, the electronic health record incentive program has been considered hardly “meaningful” by physicians struggling to meet the objectives. Up to this point, it’s seemingly been more about busywork and aimless button-clicking than meaningful work. The 2015 final rule seeks to finally change that. In the press release accompanying the announcement, Dr. Patrick Conway, CMS Deputy Administrator, offered the following:

“We have a shared goal of electronic health records helping physicians, clinicians, and hospitals to deliver better care, smarter spending, and healthier people. We eliminated unnecessary requirements, simplified and increased flexibility for those that remain, and focused on interoperability, information exchange, and patient engagement.”

Expanding on his comments, we’ll first point out the change in length of the meaningful use reporting period. In 2015, it has been shortened to 90 days, regardless of stage. For most, this will elicit a huge sigh of relief, as providers now have the option to choose any continuous 90-day period within 2015 instead of being forced to report for the full year. This fundamental change adds tremendous flexibility to the program, as it eliminates the do-or-die scenario of full-year reporting and allows providers to retrospectively select an optimal attestation period.

Next is the streamlining of the required measures. From 20 measures, the list has been brought down to 10: 9 core objectives and 1 public health objective. In doing this, the CMS sought to remove the “checkbox processes” that have become a much-maligned hallmark of meaningful use. The agency also made an attempt to remove measures considered redundant, duplicative, or topped-out (such as demographic and vital sign documentation). Finally, the CMS essentially removed the core and menu structure and consolidated all measures, so that all providers are working off the same playbook, regardless of stage.

Third, and perhaps most interestingly, is the focus of the remaining objectives. As Dr. Conway related, the measures that the CMS has chosen to retain aim very clearly at a few key goals, with data-sharing principal among them. In fact, more than half the measures rely on information exchange. CMS has admitted that efforts thus far have not produced the kind of transformational interoperability intended, but that ultimately this is the direction EHRs need to take if they are to fulfill their true promise. Although we tend to agree (and we will be writing in greater detail about this in future columns), we feel it’s important to note that this will continue to be challenging for providers and vendors. Until data standards are universally adopted by EHR vendors, health care providers will be forced to bear the burden of imperfect interoperability.

Fortunately, one area in which the burden on physicians has been lightened is patient participation in meaningful use. The CMS has realized the impracticality of measures that rely completely on patients for success and removed the compliance thresholds for secure electronic messages and electronic portal usage. These tools need to be made available to patients, but providers are no longer held responsible for whether or not a certain percentage of patients choose to use them. In 2015, only one patient needs to “view, download, or transmit” information through a patient portal, and secure email capability only needs to be enabled, even if no one opts to use it.

Finally, the CMS is clear to point out that it sympathizes with those who have been unsuccessful in attaining meaningful use, encouraging them to submit requests for hardship exceptions “through the existing request process.” Unfortunately, this process is fairly narrow in scope and really only applies in cases of vendor delays or significant unforeseen consequences (such as bankruptcy, fire, or natural disasters). Still, there is no penalty in applying for an exception even if it is not granted, so, while CMS plans to grant only a limited number of exceptions, we would echo the encouragement to apply if needed.

What’s next?

The 2015 final rule is yet another step in laying groundwork for Meaningful Use stage III, which will be optional in 2017 and mandatory in 2018. The delay offers providers and vendors additional time to adapt and comply with the new regulations, while hopefully adding simplicity and flexibility to the process. Ultimately, this also better aligns reporting Meaningful Use with other incentive programs, all of which will be eventually consolidated under MIPS, the Merit-based Incentive Payment System (we’ll have more on this in a later column, but we want you to know that it is a new system of value-based reimbursement that will sunset the Meaningful Use payment adjustment at the end of calendar year 2018).

We applaud the efforts taken by CMS and the Office of the National Coordinator for Health IT to further streamline the Meaningful Use program and agree with their intent. According to the press release, they have attempted to “shift the paradigm so health IT becomes a tool for care improvement, not an end in itself.” We firmly believe in this idea, and are ultimately encouraged by the 2015 final rule.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

On Oct. 6, after many months of anticipation, the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health IT published the 2015 Meaningful Use final rule. This long-awaited document, weighing in at almost 800 pages, contains some major changes to the Meaningful Use program beginning this year. By the time you read this, you’ll no doubt have heard about the major aspects of the changes. Regardless, we thought it would be useful to focus our lens on the new rules and consider how they will translate from the legislature into the real world.

What’s new?

Contrary to its name, the electronic health record incentive program has been considered hardly “meaningful” by physicians struggling to meet the objectives. Up to this point, it’s seemingly been more about busywork and aimless button-clicking than meaningful work. The 2015 final rule seeks to finally change that. In the press release accompanying the announcement, Dr. Patrick Conway, CMS Deputy Administrator, offered the following:

“We have a shared goal of electronic health records helping physicians, clinicians, and hospitals to deliver better care, smarter spending, and healthier people. We eliminated unnecessary requirements, simplified and increased flexibility for those that remain, and focused on interoperability, information exchange, and patient engagement.”

Expanding on his comments, we’ll first point out the change in length of the meaningful use reporting period. In 2015, it has been shortened to 90 days, regardless of stage. For most, this will elicit a huge sigh of relief, as providers now have the option to choose any continuous 90-day period within 2015 instead of being forced to report for the full year. This fundamental change adds tremendous flexibility to the program, as it eliminates the do-or-die scenario of full-year reporting and allows providers to retrospectively select an optimal attestation period.

Next is the streamlining of the required measures. From 20 measures, the list has been brought down to 10: 9 core objectives and 1 public health objective. In doing this, the CMS sought to remove the “checkbox processes” that have become a much-maligned hallmark of meaningful use. The agency also made an attempt to remove measures considered redundant, duplicative, or topped-out (such as demographic and vital sign documentation). Finally, the CMS essentially removed the core and menu structure and consolidated all measures, so that all providers are working off the same playbook, regardless of stage.

Third, and perhaps most interestingly, is the focus of the remaining objectives. As Dr. Conway related, the measures that the CMS has chosen to retain aim very clearly at a few key goals, with data-sharing principal among them. In fact, more than half the measures rely on information exchange. CMS has admitted that efforts thus far have not produced the kind of transformational interoperability intended, but that ultimately this is the direction EHRs need to take if they are to fulfill their true promise. Although we tend to agree (and we will be writing in greater detail about this in future columns), we feel it’s important to note that this will continue to be challenging for providers and vendors. Until data standards are universally adopted by EHR vendors, health care providers will be forced to bear the burden of imperfect interoperability.

Fortunately, one area in which the burden on physicians has been lightened is patient participation in meaningful use. The CMS has realized the impracticality of measures that rely completely on patients for success and removed the compliance thresholds for secure electronic messages and electronic portal usage. These tools need to be made available to patients, but providers are no longer held responsible for whether or not a certain percentage of patients choose to use them. In 2015, only one patient needs to “view, download, or transmit” information through a patient portal, and secure email capability only needs to be enabled, even if no one opts to use it.

Finally, the CMS is clear to point out that it sympathizes with those who have been unsuccessful in attaining meaningful use, encouraging them to submit requests for hardship exceptions “through the existing request process.” Unfortunately, this process is fairly narrow in scope and really only applies in cases of vendor delays or significant unforeseen consequences (such as bankruptcy, fire, or natural disasters). Still, there is no penalty in applying for an exception even if it is not granted, so, while CMS plans to grant only a limited number of exceptions, we would echo the encouragement to apply if needed.

What’s next?

The 2015 final rule is yet another step in laying groundwork for Meaningful Use stage III, which will be optional in 2017 and mandatory in 2018. The delay offers providers and vendors additional time to adapt and comply with the new regulations, while hopefully adding simplicity and flexibility to the process. Ultimately, this also better aligns reporting Meaningful Use with other incentive programs, all of which will be eventually consolidated under MIPS, the Merit-based Incentive Payment System (we’ll have more on this in a later column, but we want you to know that it is a new system of value-based reimbursement that will sunset the Meaningful Use payment adjustment at the end of calendar year 2018).

We applaud the efforts taken by CMS and the Office of the National Coordinator for Health IT to further streamline the Meaningful Use program and agree with their intent. According to the press release, they have attempted to “shift the paradigm so health IT becomes a tool for care improvement, not an end in itself.” We firmly believe in this idea, and are ultimately encouraged by the 2015 final rule.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

The deadline to conduct an informal review of your 2016 value modifier under the Physician Quality Reporting System (PQRS) is Nov. 9, 2015.

The Centers for Medicare & Medicaid Services announced the preview of 2014 annual Quality and Resource Use Reports for all group and solo providers nationwide, accessible by taxpayer identification number. Reports also are available for participants in the Medicare Shared Savings Program, the Pioneer ACO Model, or the Comprehensive Primary Care Initiative in 2014.

©sndr/istockphoto.com

The reports show 2014 performance levels on quality and cost measures that will be used to calculate the 2016 value modifier. For groups of 10 or more, the report also will show the affect of the modifier on their physician fee schedule payments. For smaller groups and solo providers, the report is informational only and will not affect payments.

The report can be accessed on the CMS Enterprise Portal. The agency’s website also provides information on how to access the report.

gtwachtman@frontlinemedcom.com

The deadline to conduct an informal review of your 2016 value modifier under the Physician Quality Reporting System (PQRS) is Nov. 9, 2015.

The Centers for Medicare & Medicaid Services announced the preview of 2014 annual Quality and Resource Use Reports for all group and solo providers nationwide, accessible by taxpayer identification number. Reports also are available for participants in the Medicare Shared Savings Program, the Pioneer ACO Model, or the Comprehensive Primary Care Initiative in 2014.

©sndr/istockphoto.com

The reports show 2014 performance levels on quality and cost measures that will be used to calculate the 2016 value modifier. For groups of 10 or more, the report also will show the affect of the modifier on their physician fee schedule payments. For smaller groups and solo providers, the report is informational only and will not affect payments.

The report can be accessed on the CMS Enterprise Portal. The agency’s website also provides information on how to access the report.

gtwachtman@frontlinemedcom.com

The deadline to conduct an informal review of your 2016 value modifier under the Physician Quality Reporting System (PQRS) is Nov. 9, 2015.

The Centers for Medicare & Medicaid Services announced the preview of 2014 annual Quality and Resource Use Reports for all group and solo providers nationwide, accessible by taxpayer identification number. Reports also are available for participants in the Medicare Shared Savings Program, the Pioneer ACO Model, or the Comprehensive Primary Care Initiative in 2014.

©sndr/istockphoto.com

The reports show 2014 performance levels on quality and cost measures that will be used to calculate the 2016 value modifier. For groups of 10 or more, the report also will show the affect of the modifier on their physician fee schedule payments. For smaller groups and solo providers, the report is informational only and will not affect payments.

The report can be accessed on the CMS Enterprise Portal. The agency’s website also provides information on how to access the report.

gtwachtman@frontlinemedcom.com

Department of Health and Human Services officials on October 15 predicted that about an additional 1 million Americans would sign up for coverage under the federal health law next year and acknowledged that prospective enrollees are worried about the cost of health insurance, even with the law’s financial help.

“We know the remaining uninsured have a lot of concerns about whether they can afford coverage,” HHS Secretary Sylvia Mathews Burwell told reporters. According to an HHS analysis, nearly eight in 10 of the approximately 10.5 million uninsured individuals likely to qualify for coverage on the health law’s online marketplaces, or exchanges, may be eligible for the financial assistance that helps people pay their monthly premiums and pay out-of-pocket costs.

Burwell said the agency is aiming to have about 10 million people enrolled and paying for coverage by the end of 2016. That’s about a million more than expected by the end of this year. She said the 2016 target is “a strong and realistic goal.”

The HHS goal of 10 million paid enrollees in 2016 is half of the June Congressional Budget Office estimate of 20 million health law enrollees. Many of those potential enrollees for 2016 are from hard-to-reach groups that have yet to sign up despite two previous enrollment campaigns. It is unclear if even 2016’s tougher tax fines — $695 or 2.5 percent of income, whichever is greater — will spur the remaining eligible uninsured to sign up in large numbers. Another hurdle is that almost 60 percent of this group either doesn’t know that financial help paying for premiums is available or they are confused about how those tax credits work, according to survey data.

The HHS analysis gives a snapshot of this eligible group. Nearly half are between the ages of 18 and 34, about 19 percent are Hispanic, 14 percent are African-American and 2 percent are Asian. And more than half are men.

Almost 40 percent are living between 139 and 250 percent of the federal poverty level, approximately $30,000 to $60,000 for a family of four, according to the HHS analysis.

HHS officials estimate that 7.3 million to 8.8 million people currently enrolled in a marketplace plan will re-enroll for 2016. They also think they’ll sign up between 2.8 million and 3.9 million of the estimated 10.5 million people eligible to enroll in coverage. About 900,000 to 1.5 million people currently covered by plans they bought outside the exchange may switch to marketplace plans, according to HHS predictions.

Varying assumptions explain the difference between the CBO estimate and the HHS target, said Richard Frank, HHS assistant secretary for planning and evaluation. The CBO assumes that more people will lose their employer-sponsored coverage and that more individuals will move from the individual market to exchange coverage, shifts that have not occurred in numbers as large as CBO predicted, Frank said.

HHS officials said the agency plans to make a series of improvements to healthcare.gov, the federal website where people can enroll in coverage, including a new “Under 30?” tab where individuals in that highly sought after demographic group can get more information about coverage.

“While our audiences may be harder to reach, we’re working smarter to reach them,” Burwell said.

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

Department of Health and Human Services officials on October 15 predicted that about an additional 1 million Americans would sign up for coverage under the federal health law next year and acknowledged that prospective enrollees are worried about the cost of health insurance, even with the law’s financial help.

“We know the remaining uninsured have a lot of concerns about whether they can afford coverage,” HHS Secretary Sylvia Mathews Burwell told reporters. According to an HHS analysis, nearly eight in 10 of the approximately 10.5 million uninsured individuals likely to qualify for coverage on the health law’s online marketplaces, or exchanges, may be eligible for the financial assistance that helps people pay their monthly premiums and pay out-of-pocket costs.

Burwell said the agency is aiming to have about 10 million people enrolled and paying for coverage by the end of 2016. That’s about a million more than expected by the end of this year. She said the 2016 target is “a strong and realistic goal.”

The HHS goal of 10 million paid enrollees in 2016 is half of the June Congressional Budget Office estimate of 20 million health law enrollees. Many of those potential enrollees for 2016 are from hard-to-reach groups that have yet to sign up despite two previous enrollment campaigns. It is unclear if even 2016’s tougher tax fines — $695 or 2.5 percent of income, whichever is greater — will spur the remaining eligible uninsured to sign up in large numbers. Another hurdle is that almost 60 percent of this group either doesn’t know that financial help paying for premiums is available or they are confused about how those tax credits work, according to survey data.

The HHS analysis gives a snapshot of this eligible group. Nearly half are between the ages of 18 and 34, about 19 percent are Hispanic, 14 percent are African-American and 2 percent are Asian. And more than half are men.

Almost 40 percent are living between 139 and 250 percent of the federal poverty level, approximately $30,000 to $60,000 for a family of four, according to the HHS analysis.

HHS officials estimate that 7.3 million to 8.8 million people currently enrolled in a marketplace plan will re-enroll for 2016. They also think they’ll sign up between 2.8 million and 3.9 million of the estimated 10.5 million people eligible to enroll in coverage. About 900,000 to 1.5 million people currently covered by plans they bought outside the exchange may switch to marketplace plans, according to HHS predictions.

Varying assumptions explain the difference between the CBO estimate and the HHS target, said Richard Frank, HHS assistant secretary for planning and evaluation. The CBO assumes that more people will lose their employer-sponsored coverage and that more individuals will move from the individual market to exchange coverage, shifts that have not occurred in numbers as large as CBO predicted, Frank said.

HHS officials said the agency plans to make a series of improvements to healthcare.gov, the federal website where people can enroll in coverage, including a new “Under 30?” tab where individuals in that highly sought after demographic group can get more information about coverage.

“While our audiences may be harder to reach, we’re working smarter to reach them,” Burwell said.

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

Department of Health and Human Services officials on October 15 predicted that about an additional 1 million Americans would sign up for coverage under the federal health law next year and acknowledged that prospective enrollees are worried about the cost of health insurance, even with the law’s financial help.

“We know the remaining uninsured have a lot of concerns about whether they can afford coverage,” HHS Secretary Sylvia Mathews Burwell told reporters. According to an HHS analysis, nearly eight in 10 of the approximately 10.5 million uninsured individuals likely to qualify for coverage on the health law’s online marketplaces, or exchanges, may be eligible for the financial assistance that helps people pay their monthly premiums and pay out-of-pocket costs.

Burwell said the agency is aiming to have about 10 million people enrolled and paying for coverage by the end of 2016. That’s about a million more than expected by the end of this year. She said the 2016 target is “a strong and realistic goal.”

The HHS goal of 10 million paid enrollees in 2016 is half of the June Congressional Budget Office estimate of 20 million health law enrollees. Many of those potential enrollees for 2016 are from hard-to-reach groups that have yet to sign up despite two previous enrollment campaigns. It is unclear if even 2016’s tougher tax fines — $695 or 2.5 percent of income, whichever is greater — will spur the remaining eligible uninsured to sign up in large numbers. Another hurdle is that almost 60 percent of this group either doesn’t know that financial help paying for premiums is available or they are confused about how those tax credits work, according to survey data.

The HHS analysis gives a snapshot of this eligible group. Nearly half are between the ages of 18 and 34, about 19 percent are Hispanic, 14 percent are African-American and 2 percent are Asian. And more than half are men.

Almost 40 percent are living between 139 and 250 percent of the federal poverty level, approximately $30,000 to $60,000 for a family of four, according to the HHS analysis.

HHS officials estimate that 7.3 million to 8.8 million people currently enrolled in a marketplace plan will re-enroll for 2016. They also think they’ll sign up between 2.8 million and 3.9 million of the estimated 10.5 million people eligible to enroll in coverage. About 900,000 to 1.5 million people currently covered by plans they bought outside the exchange may switch to marketplace plans, according to HHS predictions.

Varying assumptions explain the difference between the CBO estimate and the HHS target, said Richard Frank, HHS assistant secretary for planning and evaluation. The CBO assumes that more people will lose their employer-sponsored coverage and that more individuals will move from the individual market to exchange coverage, shifts that have not occurred in numbers as large as CBO predicted, Frank said.

HHS officials said the agency plans to make a series of improvements to healthcare.gov, the federal website where people can enroll in coverage, including a new “Under 30?” tab where individuals in that highly sought after demographic group can get more information about coverage.

“While our audiences may be harder to reach, we’re working smarter to reach them,” Burwell said.

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

Patients with bladder cancer and low scores on self-assessed mental health testing had more high-grade complications after radical cystectomy than their peers with better scores, even though their physical health was comparable, according to research published in the Journal of Urology.

The retrospective study mirrors past work linking preoperative mental disorders to adverse outcomes after major abdominal surgery, bariatric surgery, cardiac surgery, and kidney transplantation, said Dr. Pranav Sharma and his associates at Moffitt Cancer Center in Tampa. This study is the first to examine the association for bladder cancer patients who undergo radical cystectomy, according to the researchers.

They examined 30-day rates of Clavien grade IIIa or greater complications among 274 patients who filled out the Short Form 12 self-assessment of health status less than 6 months before surgery as part of a “new patient” questionnaire (J Urol. 2015. doi:10.1016/j.juro.2015.07.095). This included only 58% of radical cystectomy patients treated at Moffitt, and these patients had higher rates of positive soft-tissue margins and more aggressive pathology than did radical cystectomy patients who did not fill out the SF-12, the researchers said.

In all, 17% of patients experienced at least one high-grade complication within 30 days of their surgery. The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 score for patients who did not experience 30-day high-grade complications (P = .004). Physical composite scores did not significantly differ among patients who did and did not experience 30-day high-grade complications (median, 39.2 for patients with complications vs. 43.8 for those without; P = .06), the investigators said.

A model that incorporated known risk factors for postoperative complications – including age, body mass index, age-adjusted Charlson Comorbidity Index, American Society of Anesthesiologists score, preoperative albumin, and pathologic tumor stage – was not significantly linked with 30-day high-grade complications, even after including the SF-12 physical composite score (P = .14), Dr. Sharma and his associates reported. The association, however, became significant after they added the mental health composite score to the model (odds ratio, 0.96; 95% confidence interval, 0.93-0.99; P = .01).

“Although there is responder subjectivity associated with survey-based health-related [quality of life] measures, this finding suggests that measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy,” they wrote.

The study might have lacked statistical power to detect some associations, and the small sample size precluded the researchers from testing associations between self-reported health and specific types of complications, they noted. Also, “since we evaluated patients retrospectively, only a non-causal association between preoperative SF-12 mental composite score and high-grade 30-day complications after radical cystectomy can be suggested,” they cautioned.

The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center & Research Institute. The investigators declared no conflicts of interest.

Patients with bladder cancer and low scores on self-assessed mental health testing had more high-grade complications after radical cystectomy than their peers with better scores, even though their physical health was comparable, according to research published in the Journal of Urology.

The retrospective study mirrors past work linking preoperative mental disorders to adverse outcomes after major abdominal surgery, bariatric surgery, cardiac surgery, and kidney transplantation, said Dr. Pranav Sharma and his associates at Moffitt Cancer Center in Tampa. This study is the first to examine the association for bladder cancer patients who undergo radical cystectomy, according to the researchers.

They examined 30-day rates of Clavien grade IIIa or greater complications among 274 patients who filled out the Short Form 12 self-assessment of health status less than 6 months before surgery as part of a “new patient” questionnaire (J Urol. 2015. doi:10.1016/j.juro.2015.07.095). This included only 58% of radical cystectomy patients treated at Moffitt, and these patients had higher rates of positive soft-tissue margins and more aggressive pathology than did radical cystectomy patients who did not fill out the SF-12, the researchers said.

In all, 17% of patients experienced at least one high-grade complication within 30 days of their surgery. The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 score for patients who did not experience 30-day high-grade complications (P = .004). Physical composite scores did not significantly differ among patients who did and did not experience 30-day high-grade complications (median, 39.2 for patients with complications vs. 43.8 for those without; P = .06), the investigators said.

A model that incorporated known risk factors for postoperative complications – including age, body mass index, age-adjusted Charlson Comorbidity Index, American Society of Anesthesiologists score, preoperative albumin, and pathologic tumor stage – was not significantly linked with 30-day high-grade complications, even after including the SF-12 physical composite score (P = .14), Dr. Sharma and his associates reported. The association, however, became significant after they added the mental health composite score to the model (odds ratio, 0.96; 95% confidence interval, 0.93-0.99; P = .01).

“Although there is responder subjectivity associated with survey-based health-related [quality of life] measures, this finding suggests that measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy,” they wrote.

The study might have lacked statistical power to detect some associations, and the small sample size precluded the researchers from testing associations between self-reported health and specific types of complications, they noted. Also, “since we evaluated patients retrospectively, only a non-causal association between preoperative SF-12 mental composite score and high-grade 30-day complications after radical cystectomy can be suggested,” they cautioned.

The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center & Research Institute. The investigators declared no conflicts of interest.

Patients with bladder cancer and low scores on self-assessed mental health testing had more high-grade complications after radical cystectomy than their peers with better scores, even though their physical health was comparable, according to research published in the Journal of Urology.

The retrospective study mirrors past work linking preoperative mental disorders to adverse outcomes after major abdominal surgery, bariatric surgery, cardiac surgery, and kidney transplantation, said Dr. Pranav Sharma and his associates at Moffitt Cancer Center in Tampa. This study is the first to examine the association for bladder cancer patients who undergo radical cystectomy, according to the researchers.

They examined 30-day rates of Clavien grade IIIa or greater complications among 274 patients who filled out the Short Form 12 self-assessment of health status less than 6 months before surgery as part of a “new patient” questionnaire (J Urol. 2015. doi:10.1016/j.juro.2015.07.095). This included only 58% of radical cystectomy patients treated at Moffitt, and these patients had higher rates of positive soft-tissue margins and more aggressive pathology than did radical cystectomy patients who did not fill out the SF-12, the researchers said.

In all, 17% of patients experienced at least one high-grade complication within 30 days of their surgery. The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 score for patients who did not experience 30-day high-grade complications (P = .004). Physical composite scores did not significantly differ among patients who did and did not experience 30-day high-grade complications (median, 39.2 for patients with complications vs. 43.8 for those without; P = .06), the investigators said.

A model that incorporated known risk factors for postoperative complications – including age, body mass index, age-adjusted Charlson Comorbidity Index, American Society of Anesthesiologists score, preoperative albumin, and pathologic tumor stage – was not significantly linked with 30-day high-grade complications, even after including the SF-12 physical composite score (P = .14), Dr. Sharma and his associates reported. The association, however, became significant after they added the mental health composite score to the model (odds ratio, 0.96; 95% confidence interval, 0.93-0.99; P = .01).

“Although there is responder subjectivity associated with survey-based health-related [quality of life] measures, this finding suggests that measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy,” they wrote.

The study might have lacked statistical power to detect some associations, and the small sample size precluded the researchers from testing associations between self-reported health and specific types of complications, they noted. Also, “since we evaluated patients retrospectively, only a non-causal association between preoperative SF-12 mental composite score and high-grade 30-day complications after radical cystectomy can be suggested,” they cautioned.

The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center & Research Institute. The investigators declared no conflicts of interest.

An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.

A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.

Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.

The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.

In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”

Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).

lfranki@frontlinemedcom.com

An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.

A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.

Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.

The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.

In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”

Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).

lfranki@frontlinemedcom.com

An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.

A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.

Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.

The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.

In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”

Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).

lfranki@frontlinemedcom.com

Medicaid payment rates are holding firm, according to a survey of Medicaid directors from each state and the District of Columbia released Oct. 15 by the Kaiser Family Foundation.

“No states are now making across-the-board budget-driven cuts to Medicaid provider rates in fiscal 2016, something which we quite commonly saw only a few years ago during the economic downturn,” Vern Smith, Ph.D., managing principal of Health Management Associates, said during a press briefing on the survey.

© crazydiva/Thinkstock

Dr. Smith noted that the rate increases and decreases that are occurring are “routine and targeted in nature.”

State Medicaid programs are increasing benefits as well. “Last year, just one state limited their benefit,” and it was utilization controls applied to those who qualified for expanded Medicaid access, Dr. Smith said. For fiscal 2016, five states reported benefit restrictions. “On the other hand, over half of the states, a total of 28, expanded benefits in some way, with 24 states expanding or enhancing benefit offerings in 2015, and 18 states adopting benefit expansions/enhancements for fiscal 2016.

“The most common benefit expansion … was for behavioral health services,” Dr. Smith said. “The second most common was for long-term care service.” Other areas that had expansion of benefits were in dental services and telemedicine.

Concerns for state Medicaid programs also were identified in the survey, specifically regarding Medicaid expansion under the Affordable Care Act and cost control.

“The focus on ensuring the greatest possible value for state tax payers is always a top priority,” Dr. Smith said. “Many directors in this area specifically singled out their priority on controlling the escalating cost of specialty drugs.”

Other priorities included delivery system and payment reform initiatives and a greater focus on the social determinants of health and population health, two terms Dr. Smith described as being something new in the vocabulary of Medicaid.

“State Medicaid programs are focused on performance, value, and improving health in a way never seen before in the 50-year history of the program,” he said.

The stability of benefits and payment rates comes as Medicaid is seeing its greatest increases in enrollment and state government spending, primarily driven by the ACA. Currently, 30 states and the District of Columbia have expanded their Medicaid eligibility.

gtwachtman@frontlinemedcom.com

Medicaid payment rates are holding firm, according to a survey of Medicaid directors from each state and the District of Columbia released Oct. 15 by the Kaiser Family Foundation.

“No states are now making across-the-board budget-driven cuts to Medicaid provider rates in fiscal 2016, something which we quite commonly saw only a few years ago during the economic downturn,” Vern Smith, Ph.D., managing principal of Health Management Associates, said during a press briefing on the survey.

© crazydiva/Thinkstock

Dr. Smith noted that the rate increases and decreases that are occurring are “routine and targeted in nature.”

State Medicaid programs are increasing benefits as well. “Last year, just one state limited their benefit,” and it was utilization controls applied to those who qualified for expanded Medicaid access, Dr. Smith said. For fiscal 2016, five states reported benefit restrictions. “On the other hand, over half of the states, a total of 28, expanded benefits in some way, with 24 states expanding or enhancing benefit offerings in 2015, and 18 states adopting benefit expansions/enhancements for fiscal 2016.

“The most common benefit expansion … was for behavioral health services,” Dr. Smith said. “The second most common was for long-term care service.” Other areas that had expansion of benefits were in dental services and telemedicine.

Concerns for state Medicaid programs also were identified in the survey, specifically regarding Medicaid expansion under the Affordable Care Act and cost control.

“The focus on ensuring the greatest possible value for state tax payers is always a top priority,” Dr. Smith said. “Many directors in this area specifically singled out their priority on controlling the escalating cost of specialty drugs.”

Other priorities included delivery system and payment reform initiatives and a greater focus on the social determinants of health and population health, two terms Dr. Smith described as being something new in the vocabulary of Medicaid.

“State Medicaid programs are focused on performance, value, and improving health in a way never seen before in the 50-year history of the program,” he said.

The stability of benefits and payment rates comes as Medicaid is seeing its greatest increases in enrollment and state government spending, primarily driven by the ACA. Currently, 30 states and the District of Columbia have expanded their Medicaid eligibility.

gtwachtman@frontlinemedcom.com

Medicaid payment rates are holding firm, according to a survey of Medicaid directors from each state and the District of Columbia released Oct. 15 by the Kaiser Family Foundation.

“No states are now making across-the-board budget-driven cuts to Medicaid provider rates in fiscal 2016, something which we quite commonly saw only a few years ago during the economic downturn,” Vern Smith, Ph.D., managing principal of Health Management Associates, said during a press briefing on the survey.

© crazydiva/Thinkstock

Dr. Smith noted that the rate increases and decreases that are occurring are “routine and targeted in nature.”

State Medicaid programs are increasing benefits as well. “Last year, just one state limited their benefit,” and it was utilization controls applied to those who qualified for expanded Medicaid access, Dr. Smith said. For fiscal 2016, five states reported benefit restrictions. “On the other hand, over half of the states, a total of 28, expanded benefits in some way, with 24 states expanding or enhancing benefit offerings in 2015, and 18 states adopting benefit expansions/enhancements for fiscal 2016.

“The most common benefit expansion … was for behavioral health services,” Dr. Smith said. “The second most common was for long-term care service.” Other areas that had expansion of benefits were in dental services and telemedicine.

Concerns for state Medicaid programs also were identified in the survey, specifically regarding Medicaid expansion under the Affordable Care Act and cost control.

“The focus on ensuring the greatest possible value for state tax payers is always a top priority,” Dr. Smith said. “Many directors in this area specifically singled out their priority on controlling the escalating cost of specialty drugs.”

Other priorities included delivery system and payment reform initiatives and a greater focus on the social determinants of health and population health, two terms Dr. Smith described as being something new in the vocabulary of Medicaid.

“State Medicaid programs are focused on performance, value, and improving health in a way never seen before in the 50-year history of the program,” he said.

The stability of benefits and payment rates comes as Medicaid is seeing its greatest increases in enrollment and state government spending, primarily driven by the ACA. Currently, 30 states and the District of Columbia have expanded their Medicaid eligibility.

gtwachtman@frontlinemedcom.com

SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.

The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.

The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.

Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.

“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.

The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.

The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.

Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.

The TUXEDO-India trial was supported by Boston Scientific.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.

The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.

The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.

Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.

“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.

The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.

The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.

Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.

The TUXEDO-India trial was supported by Boston Scientific.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.

The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.

The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.

Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.

“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.

The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.

The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.

Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.

The TUXEDO-India trial was supported by Boston Scientific.

sworcester@frontlinemedcom.com