News from the SVS

Contributions to SVS PAC in 2013 served as a catalyst for several victories. These donations from SVS members provided the funds for SVS member volunteers and staff to attend fundraisers for 56 members of Congress and candidates where they were able to speak with these influential legislators to discuss the issues important to every vascular surgeon.

The SVS PAC is the only PAC that represents the specialty; no other PAC is focused solely on the interests of vascular surgeons and their patients.

The following are the notable accomplishments in 2013:

• Medicare cap on payment for services performed in angiography suites was averted

• Additional cuts to vascular ultrasound were averted

• Independent Payment Advisory Board repeal was introduced in the House and Senate with bipartisan support

• The PAC continues to work with Congressional committees to repeal and reform the Sustainable Growth Rate for reimbursement.

Complete details on these activities, articles from Drs. David Deaton, Peter Gloviczki, and Peter Lawrence, information on how PAC funds are distributed, and lists of contributors are all included in the 2013 SVS PAC Annual Report at www.svspac.org.

Please take a few minutes to read the annual report to learn how the SVS PAC is representing the interests of vascular surgeons.

Also read the list of generous contributors who make these successes possible.

Make a 2014 PAC donation now at www.svspac.org to ensure this good work continues.

Contributions to SVS PAC in 2013 served as a catalyst for several victories. These donations from SVS members provided the funds for SVS member volunteers and staff to attend fundraisers for 56 members of Congress and candidates where they were able to speak with these influential legislators to discuss the issues important to every vascular surgeon.

The SVS PAC is the only PAC that represents the specialty; no other PAC is focused solely on the interests of vascular surgeons and their patients.

The following are the notable accomplishments in 2013:

• Medicare cap on payment for services performed in angiography suites was averted

• Additional cuts to vascular ultrasound were averted

• Independent Payment Advisory Board repeal was introduced in the House and Senate with bipartisan support

• The PAC continues to work with Congressional committees to repeal and reform the Sustainable Growth Rate for reimbursement.

Complete details on these activities, articles from Drs. David Deaton, Peter Gloviczki, and Peter Lawrence, information on how PAC funds are distributed, and lists of contributors are all included in the 2013 SVS PAC Annual Report at www.svspac.org.

Please take a few minutes to read the annual report to learn how the SVS PAC is representing the interests of vascular surgeons.

Also read the list of generous contributors who make these successes possible.

Make a 2014 PAC donation now at www.svspac.org to ensure this good work continues.

Contributions to SVS PAC in 2013 served as a catalyst for several victories. These donations from SVS members provided the funds for SVS member volunteers and staff to attend fundraisers for 56 members of Congress and candidates where they were able to speak with these influential legislators to discuss the issues important to every vascular surgeon.

The SVS PAC is the only PAC that represents the specialty; no other PAC is focused solely on the interests of vascular surgeons and their patients.

The following are the notable accomplishments in 2013:

• Medicare cap on payment for services performed in angiography suites was averted

• Additional cuts to vascular ultrasound were averted

• Independent Payment Advisory Board repeal was introduced in the House and Senate with bipartisan support

• The PAC continues to work with Congressional committees to repeal and reform the Sustainable Growth Rate for reimbursement.

Complete details on these activities, articles from Drs. David Deaton, Peter Gloviczki, and Peter Lawrence, information on how PAC funds are distributed, and lists of contributors are all included in the 2013 SVS PAC Annual Report at www.svspac.org.

Please take a few minutes to read the annual report to learn how the SVS PAC is representing the interests of vascular surgeons.

Also read the list of generous contributors who make these successes possible.

Make a 2014 PAC donation now at www.svspac.org to ensure this good work continues.

It is important for SVS members to know, understand, and prepare for the upcoming changes to the Physician Quality Reporting System (PQRS). PQRS is a pay-for-reporting program that uses a combination of incentive payments and downward payment adjustments to promote reporting of quality information by eligible professionals (EPs). The program is administered by the Centers for Medicare and Medicaid Services (CMS) and affects covered professional services provided to Medicare Part-B fee-for-service beneficiaries.

The program currently provides an incentive payment of .5% through 2014 to EPs and group practices who satisfactorily report data on quality measures for covered services furnished to Medicare Part B fee-for-service beneficiaries. After 2014, the payment incentive will end and a downward payment adjustment will apply to EPs who do not satisfactorily report data on quality measures for covered professional services. This means that all EPs or group practices treating Medicare Part B fee-for-services beneficiaries that either don't report at all, or don't meet the reporting requirements set by the program, will automatically receive a downward payment adjustment. In addition to being the last year physicians can receive an incentive, 2014 will also serve as the performance year that will determine the application of the 2016 downward payment adjustment of 2%.

Key facts to know about the new PQRS requirements include:

• The percentage of applicable patients a physician must report on was lowered from 80 percent to 50 percent in order to be considered a satisfactory reporter. In addition, CMS will eliminate the six-month reporting period for 2014.
• For individual participation the number of measures that must be reported has increased from three to nine for incentive purposes. The measures must cover at least three of the National Quality Strategy domains.
• CMS will no longer recognize the reporting of one measure or one measures group, or the election of Administrative Claims reporting conducted by CMS as viable reporting options for avoiding a PQRS penalty. However, physicians may report on only three measures on 50 percent of their applicable patients to avoid the 2016 PQRS penalty.
• PQRS measures groups in 2014 will only be reportable through a registry.
• Group practices comprising 25-99 EPs may still satisfy PQRS reporting in 2014 through the GPRO web-interface.
• For group practices reporting individual measures via registry, CMS finalized its proposal to increase the number of measures that must be reported from three to nine measures and set a 50 percent threshold instead of an 80 percent threshold, which it also finalized for the individual satisfactory reporting criteria for the 2014 PQRS incentive.

It is important to note that the key fact list above is not a comprehensive list of current PQRS requirements, and it is imperative for providers to review the PQRS requirements in their entirety to determine which reporting option and measures will best work for their practice. For more detailed information regarding the new PQRS requirements, please see the  PQRS information page on the CMS.gov website.

CMS.gov contains guidance and explanation of all of the requirements for both the 2014 incentive and penalty options, as well as requirements for 2015 and beyond. The website also provides resources detailing how to get started for practices or providers who are new to PQRS reporting, as well as phone numbers and contact information for those who need assistance or have questions.

It is important for SVS members to know, understand, and prepare for the upcoming changes to the Physician Quality Reporting System (PQRS). PQRS is a pay-for-reporting program that uses a combination of incentive payments and downward payment adjustments to promote reporting of quality information by eligible professionals (EPs). The program is administered by the Centers for Medicare and Medicaid Services (CMS) and affects covered professional services provided to Medicare Part-B fee-for-service beneficiaries.

The program currently provides an incentive payment of .5% through 2014 to EPs and group practices who satisfactorily report data on quality measures for covered services furnished to Medicare Part B fee-for-service beneficiaries. After 2014, the payment incentive will end and a downward payment adjustment will apply to EPs who do not satisfactorily report data on quality measures for covered professional services. This means that all EPs or group practices treating Medicare Part B fee-for-services beneficiaries that either don't report at all, or don't meet the reporting requirements set by the program, will automatically receive a downward payment adjustment. In addition to being the last year physicians can receive an incentive, 2014 will also serve as the performance year that will determine the application of the 2016 downward payment adjustment of 2%.

Key facts to know about the new PQRS requirements include:

• The percentage of applicable patients a physician must report on was lowered from 80 percent to 50 percent in order to be considered a satisfactory reporter. In addition, CMS will eliminate the six-month reporting period for 2014.
• For individual participation the number of measures that must be reported has increased from three to nine for incentive purposes. The measures must cover at least three of the National Quality Strategy domains.
• CMS will no longer recognize the reporting of one measure or one measures group, or the election of Administrative Claims reporting conducted by CMS as viable reporting options for avoiding a PQRS penalty. However, physicians may report on only three measures on 50 percent of their applicable patients to avoid the 2016 PQRS penalty.
• PQRS measures groups in 2014 will only be reportable through a registry.
• Group practices comprising 25-99 EPs may still satisfy PQRS reporting in 2014 through the GPRO web-interface.
• For group practices reporting individual measures via registry, CMS finalized its proposal to increase the number of measures that must be reported from three to nine measures and set a 50 percent threshold instead of an 80 percent threshold, which it also finalized for the individual satisfactory reporting criteria for the 2014 PQRS incentive.

It is important to note that the key fact list above is not a comprehensive list of current PQRS requirements, and it is imperative for providers to review the PQRS requirements in their entirety to determine which reporting option and measures will best work for their practice. For more detailed information regarding the new PQRS requirements, please see the  PQRS information page on the CMS.gov website.

CMS.gov contains guidance and explanation of all of the requirements for both the 2014 incentive and penalty options, as well as requirements for 2015 and beyond. The website also provides resources detailing how to get started for practices or providers who are new to PQRS reporting, as well as phone numbers and contact information for those who need assistance or have questions.

It is important for SVS members to know, understand, and prepare for the upcoming changes to the Physician Quality Reporting System (PQRS). PQRS is a pay-for-reporting program that uses a combination of incentive payments and downward payment adjustments to promote reporting of quality information by eligible professionals (EPs). The program is administered by the Centers for Medicare and Medicaid Services (CMS) and affects covered professional services provided to Medicare Part-B fee-for-service beneficiaries.

The program currently provides an incentive payment of .5% through 2014 to EPs and group practices who satisfactorily report data on quality measures for covered services furnished to Medicare Part B fee-for-service beneficiaries. After 2014, the payment incentive will end and a downward payment adjustment will apply to EPs who do not satisfactorily report data on quality measures for covered professional services. This means that all EPs or group practices treating Medicare Part B fee-for-services beneficiaries that either don't report at all, or don't meet the reporting requirements set by the program, will automatically receive a downward payment adjustment. In addition to being the last year physicians can receive an incentive, 2014 will also serve as the performance year that will determine the application of the 2016 downward payment adjustment of 2%.

Key facts to know about the new PQRS requirements include:

• The percentage of applicable patients a physician must report on was lowered from 80 percent to 50 percent in order to be considered a satisfactory reporter. In addition, CMS will eliminate the six-month reporting period for 2014.
• For individual participation the number of measures that must be reported has increased from three to nine for incentive purposes. The measures must cover at least three of the National Quality Strategy domains.
• CMS will no longer recognize the reporting of one measure or one measures group, or the election of Administrative Claims reporting conducted by CMS as viable reporting options for avoiding a PQRS penalty. However, physicians may report on only three measures on 50 percent of their applicable patients to avoid the 2016 PQRS penalty.
• PQRS measures groups in 2014 will only be reportable through a registry.
• Group practices comprising 25-99 EPs may still satisfy PQRS reporting in 2014 through the GPRO web-interface.
• For group practices reporting individual measures via registry, CMS finalized its proposal to increase the number of measures that must be reported from three to nine measures and set a 50 percent threshold instead of an 80 percent threshold, which it also finalized for the individual satisfactory reporting criteria for the 2014 PQRS incentive.

It is important to note that the key fact list above is not a comprehensive list of current PQRS requirements, and it is imperative for providers to review the PQRS requirements in their entirety to determine which reporting option and measures will best work for their practice. For more detailed information regarding the new PQRS requirements, please see the  PQRS information page on the CMS.gov website.

CMS.gov contains guidance and explanation of all of the requirements for both the 2014 incentive and penalty options, as well as requirements for 2015 and beyond. The website also provides resources detailing how to get started for practices or providers who are new to PQRS reporting, as well as phone numbers and contact information for those who need assistance or have questions.

The Centers for Medicare and Medicaid Services (CMS) final rule for the 2014 Medicare Physician Fee Schedule has been published, and most provisions went into effect January 1. Issues included in the final rule which have an impact on vascular surgeons have been posted on the SVS website. They include:

Non-Facility Cap

CMS has deferred imposing a cap on certain office-based services, which included services provided by vascular surgeons in angiography suites, for future consideration. SVS led a coalition of physician groups opposing this cap.

AAA Screening

CMS eliminated the referral requirement as part of the Welcome to Medicare Physician Exam, which also eliminates the one-year time limit for beneficiaries who are at-risk for AAA. SVS has been persistent in getting barriers removed so more beneficiaries can take advantage of this life-saving screening.

Physician Compare Website

CMS acknowledged problems with the website and will continue to make improvements. SVS has reviewed the keywords used for vascular surgery. CMS has asked physicians to review their Provider Enrollment, Chain and Ownership System (PECOS) information for accuracy.

Value-Based Payment Modifier (VBPM)

The Department of Health and Human Services is developing and implementing a budget-neutral payment system that will use a VBPM to adjust Medicare physician fee schedule payment based on the quality and cost of care physicians deliver to beneficiaries. This will be phased in over a two-year period beginning in 2015. Additional details are posted on the SVS website.

Physician Quality Reporting System (PQRS)

CMS has increased the number of measures that must be reported from three to nine measures in order to receive incentive payments. Beginning in 2015, payment incentives will end and a downward payment adjustment will apply to physicians who do not satisfactorily report data on quality measures for covered services. Also, PQRS measures groups will only be reportable through a registry starting in 2014. Additional details are posted on the SVS website.

Items and Services in FDA Investigational Device Exemption (IDE) Clinical Studies

IDE Clinical Studies are designed to generate clinical data on safety and/or effectiveness of a clinical device. SVS expressed concerns regarding the governance process for approval or denial of reimbursement and the two requirements to ensure CMS approval. CMS removed the two requirements, but did not clarify who will comprise the reviewing body or what the pre-submission process will be. Changes will be implemented by January 1, 2015. Additional details are posted on the SVS website.

The Centers for Medicare and Medicaid Services (CMS) final rule for the 2014 Medicare Physician Fee Schedule has been published, and most provisions went into effect January 1. Issues included in the final rule which have an impact on vascular surgeons have been posted on the SVS website. They include:

Non-Facility Cap

CMS has deferred imposing a cap on certain office-based services, which included services provided by vascular surgeons in angiography suites, for future consideration. SVS led a coalition of physician groups opposing this cap.

AAA Screening

CMS eliminated the referral requirement as part of the Welcome to Medicare Physician Exam, which also eliminates the one-year time limit for beneficiaries who are at-risk for AAA. SVS has been persistent in getting barriers removed so more beneficiaries can take advantage of this life-saving screening.

Physician Compare Website

CMS acknowledged problems with the website and will continue to make improvements. SVS has reviewed the keywords used for vascular surgery. CMS has asked physicians to review their Provider Enrollment, Chain and Ownership System (PECOS) information for accuracy.

Value-Based Payment Modifier (VBPM)

The Department of Health and Human Services is developing and implementing a budget-neutral payment system that will use a VBPM to adjust Medicare physician fee schedule payment based on the quality and cost of care physicians deliver to beneficiaries. This will be phased in over a two-year period beginning in 2015. Additional details are posted on the SVS website.

Physician Quality Reporting System (PQRS)

CMS has increased the number of measures that must be reported from three to nine measures in order to receive incentive payments. Beginning in 2015, payment incentives will end and a downward payment adjustment will apply to physicians who do not satisfactorily report data on quality measures for covered services. Also, PQRS measures groups will only be reportable through a registry starting in 2014. Additional details are posted on the SVS website.

Items and Services in FDA Investigational Device Exemption (IDE) Clinical Studies

IDE Clinical Studies are designed to generate clinical data on safety and/or effectiveness of a clinical device. SVS expressed concerns regarding the governance process for approval or denial of reimbursement and the two requirements to ensure CMS approval. CMS removed the two requirements, but did not clarify who will comprise the reviewing body or what the pre-submission process will be. Changes will be implemented by January 1, 2015. Additional details are posted on the SVS website.

The Centers for Medicare and Medicaid Services (CMS) final rule for the 2014 Medicare Physician Fee Schedule has been published, and most provisions went into effect January 1. Issues included in the final rule which have an impact on vascular surgeons have been posted on the SVS website. They include:

Non-Facility Cap

CMS has deferred imposing a cap on certain office-based services, which included services provided by vascular surgeons in angiography suites, for future consideration. SVS led a coalition of physician groups opposing this cap.

AAA Screening

CMS eliminated the referral requirement as part of the Welcome to Medicare Physician Exam, which also eliminates the one-year time limit for beneficiaries who are at-risk for AAA. SVS has been persistent in getting barriers removed so more beneficiaries can take advantage of this life-saving screening.

Physician Compare Website

CMS acknowledged problems with the website and will continue to make improvements. SVS has reviewed the keywords used for vascular surgery. CMS has asked physicians to review their Provider Enrollment, Chain and Ownership System (PECOS) information for accuracy.

Value-Based Payment Modifier (VBPM)

The Department of Health and Human Services is developing and implementing a budget-neutral payment system that will use a VBPM to adjust Medicare physician fee schedule payment based on the quality and cost of care physicians deliver to beneficiaries. This will be phased in over a two-year period beginning in 2015. Additional details are posted on the SVS website.

Physician Quality Reporting System (PQRS)

CMS has increased the number of measures that must be reported from three to nine measures in order to receive incentive payments. Beginning in 2015, payment incentives will end and a downward payment adjustment will apply to physicians who do not satisfactorily report data on quality measures for covered services. Also, PQRS measures groups will only be reportable through a registry starting in 2014. Additional details are posted on the SVS website.

Items and Services in FDA Investigational Device Exemption (IDE) Clinical Studies

IDE Clinical Studies are designed to generate clinical data on safety and/or effectiveness of a clinical device. SVS expressed concerns regarding the governance process for approval or denial of reimbursement and the two requirements to ensure CMS approval. CMS removed the two requirements, but did not clarify who will comprise the reviewing body or what the pre-submission process will be. Changes will be implemented by January 1, 2015. Additional details are posted on the SVS website.

The SVS Foundation is now partnering with Vascular Cures on its Wylie Scholar Program. The Wylie Scholar Program provides a crucial career development award to outstanding surgeon-scientists conducting innovative academic research. This three-year, $150,000 grant is awarded to one promising vascular surgeon-scientist in North America annually. Vascular Cures established the Wylie Scholar Program in 1996. The partnership with SVS Foundation reflects the shared commitment of both organizations to advancing the field through development of the next generation of leading vascular surgeon-scientists.

The Vascular Cures Wylie Scholar Program created a network of 16 talented surgeon-scientists at 13 institutions around the country who are transforming patient care and who have become leaders in vascular surgery and research at major medical centers. This award has played an important role in the awardees' careers. They have, on average, received $2.8 million in subsequent national research funding. Learn more about the impact of the Wylie Scholar Program and submit an application by March 31.

The SVS Foundation is now partnering with Vascular Cures on its Wylie Scholar Program. The Wylie Scholar Program provides a crucial career development award to outstanding surgeon-scientists conducting innovative academic research. This three-year, $150,000 grant is awarded to one promising vascular surgeon-scientist in North America annually. Vascular Cures established the Wylie Scholar Program in 1996. The partnership with SVS Foundation reflects the shared commitment of both organizations to advancing the field through development of the next generation of leading vascular surgeon-scientists.

The Vascular Cures Wylie Scholar Program created a network of 16 talented surgeon-scientists at 13 institutions around the country who are transforming patient care and who have become leaders in vascular surgery and research at major medical centers. This award has played an important role in the awardees' careers. They have, on average, received $2.8 million in subsequent national research funding. Learn more about the impact of the Wylie Scholar Program and submit an application by March 31.

The SVS Foundation is now partnering with Vascular Cures on its Wylie Scholar Program. The Wylie Scholar Program provides a crucial career development award to outstanding surgeon-scientists conducting innovative academic research. This three-year, $150,000 grant is awarded to one promising vascular surgeon-scientist in North America annually. Vascular Cures established the Wylie Scholar Program in 1996. The partnership with SVS Foundation reflects the shared commitment of both organizations to advancing the field through development of the next generation of leading vascular surgeon-scientists.

The Vascular Cures Wylie Scholar Program created a network of 16 talented surgeon-scientists at 13 institutions around the country who are transforming patient care and who have become leaders in vascular surgery and research at major medical centers. This award has played an important role in the awardees' careers. They have, on average, received $2.8 million in subsequent national research funding. Learn more about the impact of the Wylie Scholar Program and submit an application by March 31.

Become a presenter at the 2014 Vascular Annual Meeting, June 5-7 in Boston, MA, and submit a late-breaking clinical trial abstract. Selected abstracts will be presented at a plenary session from 2:05 - 3:00 p.m. on Saturday, June 7. Preference will be given to prospective multi-institutional trials. Since the concept is to provide Vascular Annual Meeting attendees with "late-breaking" trial data, retrospective analyses will not be considered.

When submitting an abstract, note there is a 2,000 overall character limit and a maximum of one table, figure, graph, or image allowed. Please be sure to include the sections and responses to the questions below with the submission. The title, authors, affiliations, and answers to questions 5 and 6 are not included in the character limit. 

1. Objective

2. Methods

3. Results

4. Conclusions

5. Professional practice gap: What quality gap (limitation or problem) with the practice of vascular surgery does the research address?

6. Knowledge and/or strategies: In what way might the results of this project supplement or inform clinical or research knowledge or strategies?

Submissions of the abstract and conflict of interest disclosure forms can be sent via email attachment to [email protected] by the March 17 deadline. Please note that submissions without completed disclosure forms from all the authors will not be considered.

Registration for the Vascular Annual Meeting will open at the beginning of March. Plan to attend the premier educational event for vascular health professionals.

Become a presenter at the 2014 Vascular Annual Meeting, June 5-7 in Boston, MA, and submit a late-breaking clinical trial abstract. Selected abstracts will be presented at a plenary session from 2:05 - 3:00 p.m. on Saturday, June 7. Preference will be given to prospective multi-institutional trials. Since the concept is to provide Vascular Annual Meeting attendees with "late-breaking" trial data, retrospective analyses will not be considered.

When submitting an abstract, note there is a 2,000 overall character limit and a maximum of one table, figure, graph, or image allowed. Please be sure to include the sections and responses to the questions below with the submission. The title, authors, affiliations, and answers to questions 5 and 6 are not included in the character limit. 

1. Objective

2. Methods

3. Results

4. Conclusions

5. Professional practice gap: What quality gap (limitation or problem) with the practice of vascular surgery does the research address?

6. Knowledge and/or strategies: In what way might the results of this project supplement or inform clinical or research knowledge or strategies?

Submissions of the abstract and conflict of interest disclosure forms can be sent via email attachment to [email protected] by the March 17 deadline. Please note that submissions without completed disclosure forms from all the authors will not be considered.

Registration for the Vascular Annual Meeting will open at the beginning of March. Plan to attend the premier educational event for vascular health professionals.

Become a presenter at the 2014 Vascular Annual Meeting, June 5-7 in Boston, MA, and submit a late-breaking clinical trial abstract. Selected abstracts will be presented at a plenary session from 2:05 - 3:00 p.m. on Saturday, June 7. Preference will be given to prospective multi-institutional trials. Since the concept is to provide Vascular Annual Meeting attendees with "late-breaking" trial data, retrospective analyses will not be considered.

When submitting an abstract, note there is a 2,000 overall character limit and a maximum of one table, figure, graph, or image allowed. Please be sure to include the sections and responses to the questions below with the submission. The title, authors, affiliations, and answers to questions 5 and 6 are not included in the character limit. 

1. Objective

2. Methods

3. Results

4. Conclusions

5. Professional practice gap: What quality gap (limitation or problem) with the practice of vascular surgery does the research address?

6. Knowledge and/or strategies: In what way might the results of this project supplement or inform clinical or research knowledge or strategies?

Submissions of the abstract and conflict of interest disclosure forms can be sent via email attachment to [email protected] by the March 17 deadline. Please note that submissions without completed disclosure forms from all the authors will not be considered.

Registration for the Vascular Annual Meeting will open at the beginning of March. Plan to attend the premier educational event for vascular health professionals.

According to a recent survey by the Medical Group Management Association, less than 10 percent of physician practices are prepared for the upcoming ICD-10 implementation. This new method of coding diagnoses and hospital procedures mandated by CMS is slated to take effect on October 1. While codes change every year, the switch to ICD-10 is taking place because the current 30- year old system, ICD-9, is outdated, obsolete and inconsistent with current medical practices, according to CMS.

ICD-10 (International Classification of Diseases, version 10), represents a tremendous increase in complexity from the current ICD-9. The number of diagnostic codes will increase from nearly 14,000 to around 69,000 and procedure codes will jump from around 3,000 to roughly 87,000.

To help its members with the ICD-10 transition, an overview on the impact of ICD-10 regarding vascular surgery will be presented in a SVS ICD-10 vascular surgery webinar on April 1. This course is designed for vascular surgeons and their office staff, including practice managers, nurse practitioners, physician assistants, nurses, surgery schedulers, coders, and others who seek the transition to the ICD-10 code sets for vascular surgery.

"ICD-10 readiness is critical for reimbursement," said Carrie Bosela, RN, CPC, CPC-1, administrative director of the SVS Patient Safety Organization. "This SVS webinar will prepare participants for the most common vascular diagnoses by reviewing the crosswalk from ICD-9 to ICD-10. "

Avoid payment issues and learn to code correctly with ICD-10 through this webinar. Sign up today; the cost is $125.

According to a recent survey by the Medical Group Management Association, less than 10 percent of physician practices are prepared for the upcoming ICD-10 implementation. This new method of coding diagnoses and hospital procedures mandated by CMS is slated to take effect on October 1. While codes change every year, the switch to ICD-10 is taking place because the current 30- year old system, ICD-9, is outdated, obsolete and inconsistent with current medical practices, according to CMS.

ICD-10 (International Classification of Diseases, version 10), represents a tremendous increase in complexity from the current ICD-9. The number of diagnostic codes will increase from nearly 14,000 to around 69,000 and procedure codes will jump from around 3,000 to roughly 87,000.

To help its members with the ICD-10 transition, an overview on the impact of ICD-10 regarding vascular surgery will be presented in a SVS ICD-10 vascular surgery webinar on April 1. This course is designed for vascular surgeons and their office staff, including practice managers, nurse practitioners, physician assistants, nurses, surgery schedulers, coders, and others who seek the transition to the ICD-10 code sets for vascular surgery.

"ICD-10 readiness is critical for reimbursement," said Carrie Bosela, RN, CPC, CPC-1, administrative director of the SVS Patient Safety Organization. "This SVS webinar will prepare participants for the most common vascular diagnoses by reviewing the crosswalk from ICD-9 to ICD-10. "

Avoid payment issues and learn to code correctly with ICD-10 through this webinar. Sign up today; the cost is $125.

According to a recent survey by the Medical Group Management Association, less than 10 percent of physician practices are prepared for the upcoming ICD-10 implementation. This new method of coding diagnoses and hospital procedures mandated by CMS is slated to take effect on October 1. While codes change every year, the switch to ICD-10 is taking place because the current 30- year old system, ICD-9, is outdated, obsolete and inconsistent with current medical practices, according to CMS.

ICD-10 (International Classification of Diseases, version 10), represents a tremendous increase in complexity from the current ICD-9. The number of diagnostic codes will increase from nearly 14,000 to around 69,000 and procedure codes will jump from around 3,000 to roughly 87,000.

To help its members with the ICD-10 transition, an overview on the impact of ICD-10 regarding vascular surgery will be presented in a SVS ICD-10 vascular surgery webinar on April 1. This course is designed for vascular surgeons and their office staff, including practice managers, nurse practitioners, physician assistants, nurses, surgery schedulers, coders, and others who seek the transition to the ICD-10 code sets for vascular surgery.

"ICD-10 readiness is critical for reimbursement," said Carrie Bosela, RN, CPC, CPC-1, administrative director of the SVS Patient Safety Organization. "This SVS webinar will prepare participants for the most common vascular diagnoses by reviewing the crosswalk from ICD-9 to ICD-10. "

Avoid payment issues and learn to code correctly with ICD-10 through this webinar. Sign up today; the cost is $125.

A study published in Journal of Vascular Surgery is a "call to action" for device companies.

Women are more likely than men to suffer complications, including death, from thoracic endovascular aortic repair. The reason: surgical devices too large for women’s anatomy, according to a new study in Journal of Vascular Surgery.

"This study is a call to action to decrease device size to improve outcomes for women," said Christopher Abularrage, MD, assistant professor of surgery at Johns Hopkins University and one of the study’s investigators.

Researchers reviewed 2005-2011 data on TEVAR and found that women were nearly three times as likely to require a conduit during surgery, significantly increasing their risk of death.

Researchers also found that women had longer operative times and were at greater risk for bleeding. An abstract of the study is available at www.vsweb.org/Gender. A fact sheet for patients on thoracic aneurysms and their repair is available at www.vsweb.org/TAAforpatients.

"With the device size of TEVAR delivery systems and women’s generally smaller iliac arteries, women are more likely to have complicated access issues that directly result in increased blood loss and death," said Dr. Abularrage.

Thoracic aortic aneurysm affects 15,000 Americans each year. Previous studies have shown that women are at greater risk for death after minimally invasive surgical repair of these aneurysms, but until now, there has been no well-designed study to identify the cause of this gender disparity.

"Everyone had an inkling, but now we have proof that device size is an issue," said Julie Freischlag, MD, chair of the department of surgery at Johns Hopkins University, one of the study’s investigators and president of the Society for Vascular Surgery.

"One of the early challenges in treating vascular disease in women was recognizing the illness–for a long time we believed being female protected against vascular disease. Now we’re past that and realize that there is a whole population of patients that could be treated better with devices better matched to their anatomy."

A study published in Journal of Vascular Surgery is a "call to action" for device companies.

Women are more likely than men to suffer complications, including death, from thoracic endovascular aortic repair. The reason: surgical devices too large for women’s anatomy, according to a new study in Journal of Vascular Surgery.

"This study is a call to action to decrease device size to improve outcomes for women," said Christopher Abularrage, MD, assistant professor of surgery at Johns Hopkins University and one of the study’s investigators.

Researchers reviewed 2005-2011 data on TEVAR and found that women were nearly three times as likely to require a conduit during surgery, significantly increasing their risk of death.

Researchers also found that women had longer operative times and were at greater risk for bleeding. An abstract of the study is available at www.vsweb.org/Gender. A fact sheet for patients on thoracic aneurysms and their repair is available at www.vsweb.org/TAAforpatients.

"With the device size of TEVAR delivery systems and women’s generally smaller iliac arteries, women are more likely to have complicated access issues that directly result in increased blood loss and death," said Dr. Abularrage.

Thoracic aortic aneurysm affects 15,000 Americans each year. Previous studies have shown that women are at greater risk for death after minimally invasive surgical repair of these aneurysms, but until now, there has been no well-designed study to identify the cause of this gender disparity.

"Everyone had an inkling, but now we have proof that device size is an issue," said Julie Freischlag, MD, chair of the department of surgery at Johns Hopkins University, one of the study’s investigators and president of the Society for Vascular Surgery.

"One of the early challenges in treating vascular disease in women was recognizing the illness–for a long time we believed being female protected against vascular disease. Now we’re past that and realize that there is a whole population of patients that could be treated better with devices better matched to their anatomy."

A study published in Journal of Vascular Surgery is a "call to action" for device companies.

Women are more likely than men to suffer complications, including death, from thoracic endovascular aortic repair. The reason: surgical devices too large for women’s anatomy, according to a new study in Journal of Vascular Surgery.

"This study is a call to action to decrease device size to improve outcomes for women," said Christopher Abularrage, MD, assistant professor of surgery at Johns Hopkins University and one of the study’s investigators.

Researchers reviewed 2005-2011 data on TEVAR and found that women were nearly three times as likely to require a conduit during surgery, significantly increasing their risk of death.

Researchers also found that women had longer operative times and were at greater risk for bleeding. An abstract of the study is available at www.vsweb.org/Gender. A fact sheet for patients on thoracic aneurysms and their repair is available at www.vsweb.org/TAAforpatients.

"With the device size of TEVAR delivery systems and women’s generally smaller iliac arteries, women are more likely to have complicated access issues that directly result in increased blood loss and death," said Dr. Abularrage.

Thoracic aortic aneurysm affects 15,000 Americans each year. Previous studies have shown that women are at greater risk for death after minimally invasive surgical repair of these aneurysms, but until now, there has been no well-designed study to identify the cause of this gender disparity.

"Everyone had an inkling, but now we have proof that device size is an issue," said Julie Freischlag, MD, chair of the department of surgery at Johns Hopkins University, one of the study’s investigators and president of the Society for Vascular Surgery.

"One of the early challenges in treating vascular disease in women was recognizing the illness–for a long time we believed being female protected against vascular disease. Now we’re past that and realize that there is a whole population of patients that could be treated better with devices better matched to their anatomy."

Proper coding of insurance claims is important to reimbursement. Sean Roddy, MD, Chair of the SVS Health Policy Committee, has long had an interest in this subject and recently presented top coding tips for proper reimbursement at the Northwestern Vascular Symposium in December.

The most important method to ensure correct coding is through documentation completeness, according to Dr. Roddy. While many physicians wait until the end of the day to complete all surgery and angiography documentation, that practice may not yield the best results.

"While certain details might not be important from a clinical standpoint, they are vital to proper coding," Dr. Roddy said. "In the billing and coding world, if something is not included in the procedure notes, it did not happen and is, therefore, not reimbursable. It is important to take the time to dictate what you really did so you can be paid appropriately."

During his presentation, Dr. Roddy emphasized the importance of submitting a correct claim initially, since an original claim is much more likely to be paid than an appeal. To help ensure accuracy, Dr. Roddy recommended scrubbing software which can be customized to identify errors prior to claim submission.

"At least 10 percent of our claims have a typographical error," Dr. Roddy said. "You want to get it right the first time, not spend staff time and money appealing claims. Billing software is available on many practices' systems, but it is often not activated, updated, or used when it could be. An investment in scrubbing software helps make it right the first time."

However, do not ignore claim rejections and accept them as a loss. Instead, analyze them to see if a pattern emerges. Also remember to submit claims in a timely manner.

There are also multiple procedures in the CPT manual where two different codes describe the same procedures, so it is important to be familiar with those definitions, Dr. Roddy said in his presentation.

Unfamiliarity with definitions may result in a procedure being under-coded with less reimbursement. Also don't neglect to use the add-on codes which are used to define more difficult situations and compensate the physician for added complexity and time.

It also helps to pay attention to carrier-specific billing rules. Staff needs to know dates, providers, modifiers -- rejections reports sometimes hold the key to this information. Coding staff should also be aware of Medicare's many rules, including local coverage determinations.

Following his Northwestern presentation, Dr. Roddy and Robert Zwolak, MD, gave the Society's first-ever Webinar, 2014 CPT Coding Update, which is available on demand through January 31. SVS has additional resources to help its members improve reimbursement through proper coding, including the annual coding workshop and the recently released Coding Guide 2014.

"There are coding changes annually and someone in every vascular surgery practice has to know what's new each year," Dr. Roddy said.

"Doctors focus on patient care and may pay less attention to coding. But if you don't focus on coding, someone in your practice has to do it for you," he concluded.

Proper coding of insurance claims is important to reimbursement. Sean Roddy, MD, Chair of the SVS Health Policy Committee, has long had an interest in this subject and recently presented top coding tips for proper reimbursement at the Northwestern Vascular Symposium in December.

The most important method to ensure correct coding is through documentation completeness, according to Dr. Roddy. While many physicians wait until the end of the day to complete all surgery and angiography documentation, that practice may not yield the best results.

"While certain details might not be important from a clinical standpoint, they are vital to proper coding," Dr. Roddy said. "In the billing and coding world, if something is not included in the procedure notes, it did not happen and is, therefore, not reimbursable. It is important to take the time to dictate what you really did so you can be paid appropriately."

During his presentation, Dr. Roddy emphasized the importance of submitting a correct claim initially, since an original claim is much more likely to be paid than an appeal. To help ensure accuracy, Dr. Roddy recommended scrubbing software which can be customized to identify errors prior to claim submission.

"At least 10 percent of our claims have a typographical error," Dr. Roddy said. "You want to get it right the first time, not spend staff time and money appealing claims. Billing software is available on many practices' systems, but it is often not activated, updated, or used when it could be. An investment in scrubbing software helps make it right the first time."

However, do not ignore claim rejections and accept them as a loss. Instead, analyze them to see if a pattern emerges. Also remember to submit claims in a timely manner.

There are also multiple procedures in the CPT manual where two different codes describe the same procedures, so it is important to be familiar with those definitions, Dr. Roddy said in his presentation.

Unfamiliarity with definitions may result in a procedure being under-coded with less reimbursement. Also don't neglect to use the add-on codes which are used to define more difficult situations and compensate the physician for added complexity and time.

It also helps to pay attention to carrier-specific billing rules. Staff needs to know dates, providers, modifiers -- rejections reports sometimes hold the key to this information. Coding staff should also be aware of Medicare's many rules, including local coverage determinations.

Following his Northwestern presentation, Dr. Roddy and Robert Zwolak, MD, gave the Society's first-ever Webinar, 2014 CPT Coding Update, which is available on demand through January 31. SVS has additional resources to help its members improve reimbursement through proper coding, including the annual coding workshop and the recently released Coding Guide 2014.

"There are coding changes annually and someone in every vascular surgery practice has to know what's new each year," Dr. Roddy said.

"Doctors focus on patient care and may pay less attention to coding. But if you don't focus on coding, someone in your practice has to do it for you," he concluded.

Proper coding of insurance claims is important to reimbursement. Sean Roddy, MD, Chair of the SVS Health Policy Committee, has long had an interest in this subject and recently presented top coding tips for proper reimbursement at the Northwestern Vascular Symposium in December.

The most important method to ensure correct coding is through documentation completeness, according to Dr. Roddy. While many physicians wait until the end of the day to complete all surgery and angiography documentation, that practice may not yield the best results.

"While certain details might not be important from a clinical standpoint, they are vital to proper coding," Dr. Roddy said. "In the billing and coding world, if something is not included in the procedure notes, it did not happen and is, therefore, not reimbursable. It is important to take the time to dictate what you really did so you can be paid appropriately."

During his presentation, Dr. Roddy emphasized the importance of submitting a correct claim initially, since an original claim is much more likely to be paid than an appeal. To help ensure accuracy, Dr. Roddy recommended scrubbing software which can be customized to identify errors prior to claim submission.

"At least 10 percent of our claims have a typographical error," Dr. Roddy said. "You want to get it right the first time, not spend staff time and money appealing claims. Billing software is available on many practices' systems, but it is often not activated, updated, or used when it could be. An investment in scrubbing software helps make it right the first time."

However, do not ignore claim rejections and accept them as a loss. Instead, analyze them to see if a pattern emerges. Also remember to submit claims in a timely manner.

There are also multiple procedures in the CPT manual where two different codes describe the same procedures, so it is important to be familiar with those definitions, Dr. Roddy said in his presentation.

Unfamiliarity with definitions may result in a procedure being under-coded with less reimbursement. Also don't neglect to use the add-on codes which are used to define more difficult situations and compensate the physician for added complexity and time.

It also helps to pay attention to carrier-specific billing rules. Staff needs to know dates, providers, modifiers -- rejections reports sometimes hold the key to this information. Coding staff should also be aware of Medicare's many rules, including local coverage determinations.

Following his Northwestern presentation, Dr. Roddy and Robert Zwolak, MD, gave the Society's first-ever Webinar, 2014 CPT Coding Update, which is available on demand through January 31. SVS has additional resources to help its members improve reimbursement through proper coding, including the annual coding workshop and the recently released Coding Guide 2014.

"There are coding changes annually and someone in every vascular surgery practice has to know what's new each year," Dr. Roddy said.

"Doctors focus on patient care and may pay less attention to coding. But if you don't focus on coding, someone in your practice has to do it for you," he concluded.

How does one talk about the future? We start with a look at our recent past. We looked at our recent work in five areas, carotid disease, aortic disease, peripheral vascular disease, basic science research, and outcomes research published in our "Bible," the Journal of Vascular Surgery.

First let’s talk about carotid disease. We chose the article from the Vascular Study Group of New England titled Optimal selection of asymptomatic patients for carotid endarterectomy based on predicted 5-year survival by Wallaert et al. (J. Vasc. Surg. 2013;58:112-9). This article emphasized the importance of our Vascular Quality Initiative (VQI). I believe our VQI registry is one of the most important contributions that SVS has made to outcomes research. In this article, they look at the optimal selection of patients with asymptomatic carotid artery disease to answer the question, when do you do CEA in asymptomatic patients?

The current guidelines tell us that it is when your risk of perioperative stroke or death is less than three percent and patient’s life expectancy is greater than five years. The Vascular Study Group of New England looked at long-term survival in their database to see if they could predict who would benefit from a CEA. All of us have a thought about what it is, but this study actually gives us data. They looked at minor risk factors and major risk factors, such as age, renal failure, diabetes, and contralateral occlusion and high stenosis, and showed those patients don’t do as well. There is a differentiation in five years.

That doesn’t mean that every old, contralateral occluded, diabetic person you see shouldn’t get an operation, but it does show that it’s something you should know in your practice. It’s something you should review with your patient, that there is a differentiation between patients and their outcomes.

If you are doing a prophylactic operation, the patient needs to live in order for you to prophylax them, and this article helps you determine which patients will benefit.

For aortic disease, we chose this article from the Cleveland Clinic, titled Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms by Kitagawa et al. (J. Vasc. Surg. 2013;58:625-34).

This group examined the use of fenestrated devices in the repair of chronic type B aortic dissections, using good data and follow-up. The authors looked at dissections that were very limited and those that were complicated. What they found is that the outcomes with limited dissections are quite good, but extensive dissections do have more problems, specifically endoleaks. However, the bottom line is that this new endovascular approach gives very good results for high-risk patients who would not do well with open surgery for this complex problem.

Now, for peripheral vascular disease, we really are lucky to have this study, Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease by Geraghty et al. (J. Vasc. Surg. 2013;58:386-95), because one of our strengths as vascular surgeons is the prospective randomized trial.

The VIBRANT trial looked at the Viabahn endoprosthesis versus the bare nitinol stent in complex superficial femoral artery occlusive disease.

The study shows that primary patency – which now goes out to almost three to five years – primary assisted patency, and secondary patency were similar in both groups. Thus the more expensive covered stent is not better than the bare nitinol stent in SFA disease. What I found impressive is that patency overall is quite good. It does appear, with our medications and our choices of patients, that patency rates are reasonable three to four years out.

Our basic science research study, Alpha1-adregergic receptors mediate combined signals initiated by mechanical stretch stress and norepinephrine leading to accelerated mouse vein graft atherosclerosis, by Liu et al. (J. Vasc. Surg. 2013;57:1645-56), focuses on intimal hyperplasia.

The authors examined the effects of mechanical stretch, which we know causes intimal hyperplasia, and norepinephrine on vascular remodeling. They found that adrenergic receptors mediate both pathways, leading to proliferation of vascular smooth muscle cells and accelerated intimal hyperplasia. Their data suggest that perhaps a drug aimed at these receptors could ameliorate some of the development of intimal hyperplasia. They go on to show that this is indeed the case in their model, and this has important clinical implications.

Lastly, we come to outcomes research. We chose this article by Vogel and Kruse, titled Risk factors for readmission after lower extremity procedures for peripheral artery disease (J. Vasc. Surg. 2013;58:90-7). We’ve heard for years from many of our heroes in vascular surgery, that outcomes are everything. We have outcomes–we know if our patients are dead or alive, leg on or not, stroke, yes or no. But now we are going to be able to do that with VQI.

This study looked at whether our minimally invasive procedures are associated with decreased readmission, versus our open ones with peripheral arterial work. They looked at what made people come back in the hospital, and it doesn’t look like it’s the procedure. It’s the patient. We’ve seen this in many other diseases. It’s the frailty and the inability of the patients to take care of themselves at home that gets them back. In this study, risk factors are male gender, sepsis, longer hospital stay, elevated liver enzymes, and increased medication use.

That’s a snapshot of what I see of our issues, making sure we have outcomes registries, continuing prospective randomized trials, basic science research, and if you are using new devices, comparing them to know whether they’re better, or at least as good as current ones. As we go forward, we will have to prove those things. I am confident that we will face whatever challenges happen with good data and excellent care for our patients.

Dr. Freischlag is the SVS President. Her comments were edited and condensed by Natalia Glebova, MD, from a presentation at the Northwestern Vascular Symposium in December 2013.

How does one talk about the future? We start with a look at our recent past. We looked at our recent work in five areas, carotid disease, aortic disease, peripheral vascular disease, basic science research, and outcomes research published in our "Bible," the Journal of Vascular Surgery.

First let’s talk about carotid disease. We chose the article from the Vascular Study Group of New England titled Optimal selection of asymptomatic patients for carotid endarterectomy based on predicted 5-year survival by Wallaert et al. (J. Vasc. Surg. 2013;58:112-9). This article emphasized the importance of our Vascular Quality Initiative (VQI). I believe our VQI registry is one of the most important contributions that SVS has made to outcomes research. In this article, they look at the optimal selection of patients with asymptomatic carotid artery disease to answer the question, when do you do CEA in asymptomatic patients?

The current guidelines tell us that it is when your risk of perioperative stroke or death is less than three percent and patient’s life expectancy is greater than five years. The Vascular Study Group of New England looked at long-term survival in their database to see if they could predict who would benefit from a CEA. All of us have a thought about what it is, but this study actually gives us data. They looked at minor risk factors and major risk factors, such as age, renal failure, diabetes, and contralateral occlusion and high stenosis, and showed those patients don’t do as well. There is a differentiation in five years.

That doesn’t mean that every old, contralateral occluded, diabetic person you see shouldn’t get an operation, but it does show that it’s something you should know in your practice. It’s something you should review with your patient, that there is a differentiation between patients and their outcomes.

If you are doing a prophylactic operation, the patient needs to live in order for you to prophylax them, and this article helps you determine which patients will benefit.

For aortic disease, we chose this article from the Cleveland Clinic, titled Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms by Kitagawa et al. (J. Vasc. Surg. 2013;58:625-34).

This group examined the use of fenestrated devices in the repair of chronic type B aortic dissections, using good data and follow-up. The authors looked at dissections that were very limited and those that were complicated. What they found is that the outcomes with limited dissections are quite good, but extensive dissections do have more problems, specifically endoleaks. However, the bottom line is that this new endovascular approach gives very good results for high-risk patients who would not do well with open surgery for this complex problem.

Now, for peripheral vascular disease, we really are lucky to have this study, Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease by Geraghty et al. (J. Vasc. Surg. 2013;58:386-95), because one of our strengths as vascular surgeons is the prospective randomized trial.

The VIBRANT trial looked at the Viabahn endoprosthesis versus the bare nitinol stent in complex superficial femoral artery occlusive disease.

The study shows that primary patency – which now goes out to almost three to five years – primary assisted patency, and secondary patency were similar in both groups. Thus the more expensive covered stent is not better than the bare nitinol stent in SFA disease. What I found impressive is that patency overall is quite good. It does appear, with our medications and our choices of patients, that patency rates are reasonable three to four years out.

Our basic science research study, Alpha1-adregergic receptors mediate combined signals initiated by mechanical stretch stress and norepinephrine leading to accelerated mouse vein graft atherosclerosis, by Liu et al. (J. Vasc. Surg. 2013;57:1645-56), focuses on intimal hyperplasia.

The authors examined the effects of mechanical stretch, which we know causes intimal hyperplasia, and norepinephrine on vascular remodeling. They found that adrenergic receptors mediate both pathways, leading to proliferation of vascular smooth muscle cells and accelerated intimal hyperplasia. Their data suggest that perhaps a drug aimed at these receptors could ameliorate some of the development of intimal hyperplasia. They go on to show that this is indeed the case in their model, and this has important clinical implications.

Lastly, we come to outcomes research. We chose this article by Vogel and Kruse, titled Risk factors for readmission after lower extremity procedures for peripheral artery disease (J. Vasc. Surg. 2013;58:90-7). We’ve heard for years from many of our heroes in vascular surgery, that outcomes are everything. We have outcomes–we know if our patients are dead or alive, leg on or not, stroke, yes or no. But now we are going to be able to do that with VQI.

This study looked at whether our minimally invasive procedures are associated with decreased readmission, versus our open ones with peripheral arterial work. They looked at what made people come back in the hospital, and it doesn’t look like it’s the procedure. It’s the patient. We’ve seen this in many other diseases. It’s the frailty and the inability of the patients to take care of themselves at home that gets them back. In this study, risk factors are male gender, sepsis, longer hospital stay, elevated liver enzymes, and increased medication use.

That’s a snapshot of what I see of our issues, making sure we have outcomes registries, continuing prospective randomized trials, basic science research, and if you are using new devices, comparing them to know whether they’re better, or at least as good as current ones. As we go forward, we will have to prove those things. I am confident that we will face whatever challenges happen with good data and excellent care for our patients.

Dr. Freischlag is the SVS President. Her comments were edited and condensed by Natalia Glebova, MD, from a presentation at the Northwestern Vascular Symposium in December 2013.

How does one talk about the future? We start with a look at our recent past. We looked at our recent work in five areas, carotid disease, aortic disease, peripheral vascular disease, basic science research, and outcomes research published in our "Bible," the Journal of Vascular Surgery.

First let’s talk about carotid disease. We chose the article from the Vascular Study Group of New England titled Optimal selection of asymptomatic patients for carotid endarterectomy based on predicted 5-year survival by Wallaert et al. (J. Vasc. Surg. 2013;58:112-9). This article emphasized the importance of our Vascular Quality Initiative (VQI). I believe our VQI registry is one of the most important contributions that SVS has made to outcomes research. In this article, they look at the optimal selection of patients with asymptomatic carotid artery disease to answer the question, when do you do CEA in asymptomatic patients?

The current guidelines tell us that it is when your risk of perioperative stroke or death is less than three percent and patient’s life expectancy is greater than five years. The Vascular Study Group of New England looked at long-term survival in their database to see if they could predict who would benefit from a CEA. All of us have a thought about what it is, but this study actually gives us data. They looked at minor risk factors and major risk factors, such as age, renal failure, diabetes, and contralateral occlusion and high stenosis, and showed those patients don’t do as well. There is a differentiation in five years.

That doesn’t mean that every old, contralateral occluded, diabetic person you see shouldn’t get an operation, but it does show that it’s something you should know in your practice. It’s something you should review with your patient, that there is a differentiation between patients and their outcomes.

If you are doing a prophylactic operation, the patient needs to live in order for you to prophylax them, and this article helps you determine which patients will benefit.

For aortic disease, we chose this article from the Cleveland Clinic, titled Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms by Kitagawa et al. (J. Vasc. Surg. 2013;58:625-34).

This group examined the use of fenestrated devices in the repair of chronic type B aortic dissections, using good data and follow-up. The authors looked at dissections that were very limited and those that were complicated. What they found is that the outcomes with limited dissections are quite good, but extensive dissections do have more problems, specifically endoleaks. However, the bottom line is that this new endovascular approach gives very good results for high-risk patients who would not do well with open surgery for this complex problem.

Now, for peripheral vascular disease, we really are lucky to have this study, Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease by Geraghty et al. (J. Vasc. Surg. 2013;58:386-95), because one of our strengths as vascular surgeons is the prospective randomized trial.

The VIBRANT trial looked at the Viabahn endoprosthesis versus the bare nitinol stent in complex superficial femoral artery occlusive disease.

The study shows that primary patency – which now goes out to almost three to five years – primary assisted patency, and secondary patency were similar in both groups. Thus the more expensive covered stent is not better than the bare nitinol stent in SFA disease. What I found impressive is that patency overall is quite good. It does appear, with our medications and our choices of patients, that patency rates are reasonable three to four years out.

Our basic science research study, Alpha1-adregergic receptors mediate combined signals initiated by mechanical stretch stress and norepinephrine leading to accelerated mouse vein graft atherosclerosis, by Liu et al. (J. Vasc. Surg. 2013;57:1645-56), focuses on intimal hyperplasia.

The authors examined the effects of mechanical stretch, which we know causes intimal hyperplasia, and norepinephrine on vascular remodeling. They found that adrenergic receptors mediate both pathways, leading to proliferation of vascular smooth muscle cells and accelerated intimal hyperplasia. Their data suggest that perhaps a drug aimed at these receptors could ameliorate some of the development of intimal hyperplasia. They go on to show that this is indeed the case in their model, and this has important clinical implications.

Lastly, we come to outcomes research. We chose this article by Vogel and Kruse, titled Risk factors for readmission after lower extremity procedures for peripheral artery disease (J. Vasc. Surg. 2013;58:90-7). We’ve heard for years from many of our heroes in vascular surgery, that outcomes are everything. We have outcomes–we know if our patients are dead or alive, leg on or not, stroke, yes or no. But now we are going to be able to do that with VQI.

This study looked at whether our minimally invasive procedures are associated with decreased readmission, versus our open ones with peripheral arterial work. They looked at what made people come back in the hospital, and it doesn’t look like it’s the procedure. It’s the patient. We’ve seen this in many other diseases. It’s the frailty and the inability of the patients to take care of themselves at home that gets them back. In this study, risk factors are male gender, sepsis, longer hospital stay, elevated liver enzymes, and increased medication use.

That’s a snapshot of what I see of our issues, making sure we have outcomes registries, continuing prospective randomized trials, basic science research, and if you are using new devices, comparing them to know whether they’re better, or at least as good as current ones. As we go forward, we will have to prove those things. I am confident that we will face whatever challenges happen with good data and excellent care for our patients.

Dr. Freischlag is the SVS President. Her comments were edited and condensed by Natalia Glebova, MD, from a presentation at the Northwestern Vascular Symposium in December 2013.

Off-label use of a medical device can potentially result in medical malpractice litigation. To help physicians become familiar with the conditions under which the off-label use of a medical device is legally permissible and acceptable, O. William Brown, MD, JD, of the Oakland University William Beaumont School of Medicine, presented Legal Implications of Off-Label Device Use at the recent Northwestern Vascular Symposium.

The primary purpose of Food and Drug Administration regulation of medical devices is to provide protection for the public and to limit industry's ability to promote the off-label use of their devices. Off-label use is defined as the use of a medical device for a purpose or manner not approved by the FDA.

During his presentation, Dr. Brown stressed that it is not the intent of the FDA to limit the authority of a health care professional to utilize a legally marketed medical device. The court system has, on many occasions, supported the physician's ability to use medical devices in an off-label manner.

"However, the courts have stressed that such uses must comply with the standard of care," Dr. Brown said. "In addition, the courts have made it clear that physicians who choose to use devices off-label must have a thorough understanding and extensive experience with the use of the device on-label."

The legal system has also emphasized the importance of obtaining true informed consent in the off-label use of the medical devices. In obtaining informed consent, the physician should provide the patient with the following:

•  a full diagnosis

•  the planned procedure

•  the risks and the benefits of that procedure

•  other treatment options

•  the natural history of the disease if left untreated.

Physicians who fail to provide such data, or provide inaccurate data regarding either experience with a device, or outcome results of previous procedures, will be held liable, according to Dr. Brown.

"Interestingly, as a result of the recent court case of the United States of America versus Alfred Caronia, the FDA's ability to regulate industry's promotion of off-label use has potentially been seriously impaired," Dr. Brown said.

In that case, Mr. Caronia, a manufacturer's representative, was charged with promoting the off-label use of a drug. He was found guilty but the U.S. Court of Appeals reversed the guilty verdict. The Appellate Court ruled that the promotion of off-label use was protected under the Free Speech Clause of the first amendment. It should be stressed that this ruling questions, but does not eliminate, the FDA's ability to limit the promotion of off-label use.

"Present case law suggests that the physician, and not the manufacturer, will bear the brunt of liability if complications occur as a result of off-label use of a medical device," Dr. Brown said.

"In general, lawsuits that have been filed against the manufacturer for the off-label use of a medical device have failed. Unfortunately, this leaves the physician in a very precarious position. If injured patients are unable to successfully obtain compensation from the manufacturer, they will be left with no choice but to turn their attention to the medical profession."

Dr. Brown predicts that off-label use of medical devices will likely increase as technology tries to keep pace with the public's desire to have all vascular problems treated with minimally invasive techniques.

"Physicians must understand the legal requirements and liabilities of off-label use if they wish to spend the majority of their time in the operating room and not in the court room," Dr. Brown concluded.

Off-label use of a medical device can potentially result in medical malpractice litigation. To help physicians become familiar with the conditions under which the off-label use of a medical device is legally permissible and acceptable, O. William Brown, MD, JD, of the Oakland University William Beaumont School of Medicine, presented Legal Implications of Off-Label Device Use at the recent Northwestern Vascular Symposium.

The primary purpose of Food and Drug Administration regulation of medical devices is to provide protection for the public and to limit industry's ability to promote the off-label use of their devices. Off-label use is defined as the use of a medical device for a purpose or manner not approved by the FDA.

During his presentation, Dr. Brown stressed that it is not the intent of the FDA to limit the authority of a health care professional to utilize a legally marketed medical device. The court system has, on many occasions, supported the physician's ability to use medical devices in an off-label manner.

"However, the courts have stressed that such uses must comply with the standard of care," Dr. Brown said. "In addition, the courts have made it clear that physicians who choose to use devices off-label must have a thorough understanding and extensive experience with the use of the device on-label."

The legal system has also emphasized the importance of obtaining true informed consent in the off-label use of the medical devices. In obtaining informed consent, the physician should provide the patient with the following:

•  a full diagnosis

•  the planned procedure

•  the risks and the benefits of that procedure

•  other treatment options

•  the natural history of the disease if left untreated.

Physicians who fail to provide such data, or provide inaccurate data regarding either experience with a device, or outcome results of previous procedures, will be held liable, according to Dr. Brown.

"Interestingly, as a result of the recent court case of the United States of America versus Alfred Caronia, the FDA's ability to regulate industry's promotion of off-label use has potentially been seriously impaired," Dr. Brown said.

In that case, Mr. Caronia, a manufacturer's representative, was charged with promoting the off-label use of a drug. He was found guilty but the U.S. Court of Appeals reversed the guilty verdict. The Appellate Court ruled that the promotion of off-label use was protected under the Free Speech Clause of the first amendment. It should be stressed that this ruling questions, but does not eliminate, the FDA's ability to limit the promotion of off-label use.

"Present case law suggests that the physician, and not the manufacturer, will bear the brunt of liability if complications occur as a result of off-label use of a medical device," Dr. Brown said.

"In general, lawsuits that have been filed against the manufacturer for the off-label use of a medical device have failed. Unfortunately, this leaves the physician in a very precarious position. If injured patients are unable to successfully obtain compensation from the manufacturer, they will be left with no choice but to turn their attention to the medical profession."

Dr. Brown predicts that off-label use of medical devices will likely increase as technology tries to keep pace with the public's desire to have all vascular problems treated with minimally invasive techniques.

"Physicians must understand the legal requirements and liabilities of off-label use if they wish to spend the majority of their time in the operating room and not in the court room," Dr. Brown concluded.

Off-label use of a medical device can potentially result in medical malpractice litigation. To help physicians become familiar with the conditions under which the off-label use of a medical device is legally permissible and acceptable, O. William Brown, MD, JD, of the Oakland University William Beaumont School of Medicine, presented Legal Implications of Off-Label Device Use at the recent Northwestern Vascular Symposium.

The primary purpose of Food and Drug Administration regulation of medical devices is to provide protection for the public and to limit industry's ability to promote the off-label use of their devices. Off-label use is defined as the use of a medical device for a purpose or manner not approved by the FDA.

During his presentation, Dr. Brown stressed that it is not the intent of the FDA to limit the authority of a health care professional to utilize a legally marketed medical device. The court system has, on many occasions, supported the physician's ability to use medical devices in an off-label manner.

"However, the courts have stressed that such uses must comply with the standard of care," Dr. Brown said. "In addition, the courts have made it clear that physicians who choose to use devices off-label must have a thorough understanding and extensive experience with the use of the device on-label."

The legal system has also emphasized the importance of obtaining true informed consent in the off-label use of the medical devices. In obtaining informed consent, the physician should provide the patient with the following:

•  a full diagnosis

•  the planned procedure

•  the risks and the benefits of that procedure

•  other treatment options

•  the natural history of the disease if left untreated.

Physicians who fail to provide such data, or provide inaccurate data regarding either experience with a device, or outcome results of previous procedures, will be held liable, according to Dr. Brown.

"Interestingly, as a result of the recent court case of the United States of America versus Alfred Caronia, the FDA's ability to regulate industry's promotion of off-label use has potentially been seriously impaired," Dr. Brown said.

In that case, Mr. Caronia, a manufacturer's representative, was charged with promoting the off-label use of a drug. He was found guilty but the U.S. Court of Appeals reversed the guilty verdict. The Appellate Court ruled that the promotion of off-label use was protected under the Free Speech Clause of the first amendment. It should be stressed that this ruling questions, but does not eliminate, the FDA's ability to limit the promotion of off-label use.

"Present case law suggests that the physician, and not the manufacturer, will bear the brunt of liability if complications occur as a result of off-label use of a medical device," Dr. Brown said.

"In general, lawsuits that have been filed against the manufacturer for the off-label use of a medical device have failed. Unfortunately, this leaves the physician in a very precarious position. If injured patients are unable to successfully obtain compensation from the manufacturer, they will be left with no choice but to turn their attention to the medical profession."

Dr. Brown predicts that off-label use of medical devices will likely increase as technology tries to keep pace with the public's desire to have all vascular problems treated with minimally invasive techniques.

"Physicians must understand the legal requirements and liabilities of off-label use if they wish to spend the majority of their time in the operating room and not in the court room," Dr. Brown concluded.