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Resident Research Award Highlights Diet-Based Strategy to Prevent Vein Graft Disease

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This year’s SVS Foundation’s Resident Research Award is being presented to Kaspar M. Trocha, MD, for his research on vein graft disease. As a member of the laboratories of C. Keith Ozaki, MD, and James Mitchell, MD, along with co-first author Peter Kip, MD, and microsurgeon Ming Tao, MD, the group studies the effects of food intake immediately before surgery on vascular adaptations.

Resident Research Award winner Dr. Kaspar M. Trocha (right) shown with his mentor, Dr. C. Keith Ozaki.

Dietary restriction (reducing food intake without malnutrition) has been a topic of special interest in the science community for decades, and restricting calories in the long term has been shown to extend life and health span in a variety of species. It can also protect from overexuberant responses to trauma and ischemia-reperfusion.

Dr. Mitchell found that the benefits from long-term food restriction could be acquired as rapidly as in a few days, pointing to a potential for implementing dietary restriction recommendations prior to elective surgery.

The response to stress benefits seen following brief dietary interventions are mediated by the gaseous signaling molecule hydrogen sulfide (H2S). H2S is strongly upregulated by dietary restriction and this “rotten egg” gas seems to be protective for the cardiovascular system and has been demonstrated to be involved in vasodilation, inflammation, and atherogenesis, according to the researchers. The group’s experiments thus tested short-term protein restriction (a more feasible dietary approach for patients that observed to induce H2S) in a microsurgical mouse vein graft model.

The team discovered that cutting all protein from the animal diet for just 1 week before surgery led to increased levels of the enzyme cystathionine-gamma-lyase (CGL) that makes H2S, higher levels of the protective gaseous molecule, less early vein graft inflammation, and less eventual occlusive vein graft disease even though the animals were returned to their usual high-fat diet postop. The group also confirmed these results by constructing a new mouse strain that overexpresses CGL, and these mice were protected from vein graft disease. Conversely, blocking this enzyme negated all the beneficial effects of the dietary restriction.

According to Dr. Trocha and his colleagues, “short-term pre-operative protein restriction and manipulation of H2S stand as novel, economical approaches to enhance vein graft durability and perhaps even lessen peri-operative complications, and we are in the early stages of testing this strategy in vascular surgery patients.”

Dr. Trocha’s research was supported by the Harvard-Longwood Research Training in Vascular Surgery NIH T32 Grant and Dr. Ozaki’s NIH and American Heart Association grants. The Resident Research Award is given to one individual each year as determined by the SVS Research and Education Committee with the intent of motivating physicians early in their training to pursue their interest in research that explores the biology of vascular disease and potential translational therapies. The recognition includes plenary presentation at the Vascular Annual Meeting, a $5,000 award and a 1-year complimentary subscription to the Journal of Vascular Surgery. 

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This year’s SVS Foundation’s Resident Research Award is being presented to Kaspar M. Trocha, MD, for his research on vein graft disease. As a member of the laboratories of C. Keith Ozaki, MD, and James Mitchell, MD, along with co-first author Peter Kip, MD, and microsurgeon Ming Tao, MD, the group studies the effects of food intake immediately before surgery on vascular adaptations.

Resident Research Award winner Dr. Kaspar M. Trocha (right) shown with his mentor, Dr. C. Keith Ozaki.

Dietary restriction (reducing food intake without malnutrition) has been a topic of special interest in the science community for decades, and restricting calories in the long term has been shown to extend life and health span in a variety of species. It can also protect from overexuberant responses to trauma and ischemia-reperfusion.

Dr. Mitchell found that the benefits from long-term food restriction could be acquired as rapidly as in a few days, pointing to a potential for implementing dietary restriction recommendations prior to elective surgery.

The response to stress benefits seen following brief dietary interventions are mediated by the gaseous signaling molecule hydrogen sulfide (H2S). H2S is strongly upregulated by dietary restriction and this “rotten egg” gas seems to be protective for the cardiovascular system and has been demonstrated to be involved in vasodilation, inflammation, and atherogenesis, according to the researchers. The group’s experiments thus tested short-term protein restriction (a more feasible dietary approach for patients that observed to induce H2S) in a microsurgical mouse vein graft model.

The team discovered that cutting all protein from the animal diet for just 1 week before surgery led to increased levels of the enzyme cystathionine-gamma-lyase (CGL) that makes H2S, higher levels of the protective gaseous molecule, less early vein graft inflammation, and less eventual occlusive vein graft disease even though the animals were returned to their usual high-fat diet postop. The group also confirmed these results by constructing a new mouse strain that overexpresses CGL, and these mice were protected from vein graft disease. Conversely, blocking this enzyme negated all the beneficial effects of the dietary restriction.

According to Dr. Trocha and his colleagues, “short-term pre-operative protein restriction and manipulation of H2S stand as novel, economical approaches to enhance vein graft durability and perhaps even lessen peri-operative complications, and we are in the early stages of testing this strategy in vascular surgery patients.”

Dr. Trocha’s research was supported by the Harvard-Longwood Research Training in Vascular Surgery NIH T32 Grant and Dr. Ozaki’s NIH and American Heart Association grants. The Resident Research Award is given to one individual each year as determined by the SVS Research and Education Committee with the intent of motivating physicians early in their training to pursue their interest in research that explores the biology of vascular disease and potential translational therapies. The recognition includes plenary presentation at the Vascular Annual Meeting, a $5,000 award and a 1-year complimentary subscription to the Journal of Vascular Surgery. 

This year’s SVS Foundation’s Resident Research Award is being presented to Kaspar M. Trocha, MD, for his research on vein graft disease. As a member of the laboratories of C. Keith Ozaki, MD, and James Mitchell, MD, along with co-first author Peter Kip, MD, and microsurgeon Ming Tao, MD, the group studies the effects of food intake immediately before surgery on vascular adaptations.

Resident Research Award winner Dr. Kaspar M. Trocha (right) shown with his mentor, Dr. C. Keith Ozaki.

Dietary restriction (reducing food intake without malnutrition) has been a topic of special interest in the science community for decades, and restricting calories in the long term has been shown to extend life and health span in a variety of species. It can also protect from overexuberant responses to trauma and ischemia-reperfusion.

Dr. Mitchell found that the benefits from long-term food restriction could be acquired as rapidly as in a few days, pointing to a potential for implementing dietary restriction recommendations prior to elective surgery.

The response to stress benefits seen following brief dietary interventions are mediated by the gaseous signaling molecule hydrogen sulfide (H2S). H2S is strongly upregulated by dietary restriction and this “rotten egg” gas seems to be protective for the cardiovascular system and has been demonstrated to be involved in vasodilation, inflammation, and atherogenesis, according to the researchers. The group’s experiments thus tested short-term protein restriction (a more feasible dietary approach for patients that observed to induce H2S) in a microsurgical mouse vein graft model.

The team discovered that cutting all protein from the animal diet for just 1 week before surgery led to increased levels of the enzyme cystathionine-gamma-lyase (CGL) that makes H2S, higher levels of the protective gaseous molecule, less early vein graft inflammation, and less eventual occlusive vein graft disease even though the animals were returned to their usual high-fat diet postop. The group also confirmed these results by constructing a new mouse strain that overexpresses CGL, and these mice were protected from vein graft disease. Conversely, blocking this enzyme negated all the beneficial effects of the dietary restriction.

According to Dr. Trocha and his colleagues, “short-term pre-operative protein restriction and manipulation of H2S stand as novel, economical approaches to enhance vein graft durability and perhaps even lessen peri-operative complications, and we are in the early stages of testing this strategy in vascular surgery patients.”

Dr. Trocha’s research was supported by the Harvard-Longwood Research Training in Vascular Surgery NIH T32 Grant and Dr. Ozaki’s NIH and American Heart Association grants. The Resident Research Award is given to one individual each year as determined by the SVS Research and Education Committee with the intent of motivating physicians early in their training to pursue their interest in research that explores the biology of vascular disease and potential translational therapies. The recognition includes plenary presentation at the Vascular Annual Meeting, a $5,000 award and a 1-year complimentary subscription to the Journal of Vascular Surgery. 

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Speaking of Receptions …

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A record 17 alumni receptions, representing more than 20 vascular surgery programs, are planned for Thursday evening. All take place on the third floor of the Sheraton Boston, unless otherwise indicated. Break out the school colors! Go purple and white! Or red and blue! Or …

 

  • Cleveland Clinic, 7 to 9 p.m., Dalton Room
  • Emory University, 7 to 9 p.m., Gardner B Room
  • Harvard Medical School Hospitals Vascular Surgeons, 7 to 8:30 p.m., Commonwealth Room
  • Henry Ford Hospital Szilagyi Society, 7 to 9 p.m., Beacon B Room
  • Jobst Vascular Institute Alumni Reception, 7 to 9 p.m., Beacon F Room
  • Loyola, Northwestern, University of Chicago and Rush University Hospital, 7 to 8:30 p.m., Clarendon Room
  • Mayo Clinic, 7 to 9 p.m., Beacon D Room
  • Montefiore, 7 to 9 p.m., Liberty B/C (2nd Floor)
  • Penn Vascular Surgery, 7 to 9 p.m., Berkeley Room
  • South Asian American Vascular Society, 7 to 10 p.m., Public Garden Room (5th Floor)
  • Stanford University, 7 to 9:30 p.m., Hampton Room
  • UCLA Division of Vascular & Endovascular Surgery, 7 to 9 p.m., Beacon E Room
  • University of Birmingham Alabama and University of Florida, 7 to 8:30 p.m., Beacon A Room
  • University of Buffalo, 7 to 8:30 p.m., Beacon G Room
  • University of Maryland, 7 to 8:30 p.m., Beacon H Room
  • University of Washington, 7 to 9 p.m., Exeter Room
  • Washington University – St. Louis, 7 to 8:30 p.m., Fairfax B Room
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A record 17 alumni receptions, representing more than 20 vascular surgery programs, are planned for Thursday evening. All take place on the third floor of the Sheraton Boston, unless otherwise indicated. Break out the school colors! Go purple and white! Or red and blue! Or …

 

  • Cleveland Clinic, 7 to 9 p.m., Dalton Room
  • Emory University, 7 to 9 p.m., Gardner B Room
  • Harvard Medical School Hospitals Vascular Surgeons, 7 to 8:30 p.m., Commonwealth Room
  • Henry Ford Hospital Szilagyi Society, 7 to 9 p.m., Beacon B Room
  • Jobst Vascular Institute Alumni Reception, 7 to 9 p.m., Beacon F Room
  • Loyola, Northwestern, University of Chicago and Rush University Hospital, 7 to 8:30 p.m., Clarendon Room
  • Mayo Clinic, 7 to 9 p.m., Beacon D Room
  • Montefiore, 7 to 9 p.m., Liberty B/C (2nd Floor)
  • Penn Vascular Surgery, 7 to 9 p.m., Berkeley Room
  • South Asian American Vascular Society, 7 to 10 p.m., Public Garden Room (5th Floor)
  • Stanford University, 7 to 9:30 p.m., Hampton Room
  • UCLA Division of Vascular & Endovascular Surgery, 7 to 9 p.m., Beacon E Room
  • University of Birmingham Alabama and University of Florida, 7 to 8:30 p.m., Beacon A Room
  • University of Buffalo, 7 to 8:30 p.m., Beacon G Room
  • University of Maryland, 7 to 8:30 p.m., Beacon H Room
  • University of Washington, 7 to 9 p.m., Exeter Room
  • Washington University – St. Louis, 7 to 8:30 p.m., Fairfax B Room

A record 17 alumni receptions, representing more than 20 vascular surgery programs, are planned for Thursday evening. All take place on the third floor of the Sheraton Boston, unless otherwise indicated. Break out the school colors! Go purple and white! Or red and blue! Or …

 

  • Cleveland Clinic, 7 to 9 p.m., Dalton Room
  • Emory University, 7 to 9 p.m., Gardner B Room
  • Harvard Medical School Hospitals Vascular Surgeons, 7 to 8:30 p.m., Commonwealth Room
  • Henry Ford Hospital Szilagyi Society, 7 to 9 p.m., Beacon B Room
  • Jobst Vascular Institute Alumni Reception, 7 to 9 p.m., Beacon F Room
  • Loyola, Northwestern, University of Chicago and Rush University Hospital, 7 to 8:30 p.m., Clarendon Room
  • Mayo Clinic, 7 to 9 p.m., Beacon D Room
  • Montefiore, 7 to 9 p.m., Liberty B/C (2nd Floor)
  • Penn Vascular Surgery, 7 to 9 p.m., Berkeley Room
  • South Asian American Vascular Society, 7 to 10 p.m., Public Garden Room (5th Floor)
  • Stanford University, 7 to 9:30 p.m., Hampton Room
  • UCLA Division of Vascular & Endovascular Surgery, 7 to 9 p.m., Beacon E Room
  • University of Birmingham Alabama and University of Florida, 7 to 8:30 p.m., Beacon A Room
  • University of Buffalo, 7 to 8:30 p.m., Beacon G Room
  • University of Maryland, 7 to 8:30 p.m., Beacon H Room
  • University of Washington, 7 to 9 p.m., Exeter Room
  • Washington University – St. Louis, 7 to 8:30 p.m., Fairfax B Room
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Mix and Mingle at Opening Reception

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The Exhibit Hall opens with a flourish at 10 a.m. Thursday. During the day enjoy visits with vendors and industry representatives. Play the SVS Scavenger Hunt to try to win one of three great prizes. Visit the SVS Membership Booth. Attend Vascular Live sessions that showcase the latest research and technology. And enjoy the Opening Reception from 5 to 6:30 p.m., held in conjunction with the Interactive Poster Reception. Tickets are required for the reception and are available, for free, at the Registration Area, Exhibit Hall C foyer.

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The Exhibit Hall opens with a flourish at 10 a.m. Thursday. During the day enjoy visits with vendors and industry representatives. Play the SVS Scavenger Hunt to try to win one of three great prizes. Visit the SVS Membership Booth. Attend Vascular Live sessions that showcase the latest research and technology. And enjoy the Opening Reception from 5 to 6:30 p.m., held in conjunction with the Interactive Poster Reception. Tickets are required for the reception and are available, for free, at the Registration Area, Exhibit Hall C foyer.

The Exhibit Hall opens with a flourish at 10 a.m. Thursday. During the day enjoy visits with vendors and industry representatives. Play the SVS Scavenger Hunt to try to win one of three great prizes. Visit the SVS Membership Booth. Attend Vascular Live sessions that showcase the latest research and technology. And enjoy the Opening Reception from 5 to 6:30 p.m., held in conjunction with the Interactive Poster Reception. Tickets are required for the reception and are available, for free, at the Registration Area, Exhibit Hall C foyer.

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Launching the Moderate to Severe Asthma Center of Excellence

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The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

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The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

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 We're on Instagram!

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We're now on Instagram, a social media app designed for sharing photos and videos from a smartphone. Be sure to follow us!

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We're now on Instagram, a social media app designed for sharing photos and videos from a smartphone. Be sure to follow us!

We're now on Instagram, a social media app designed for sharing photos and videos from a smartphone. Be sure to follow us!

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Going to VAM? Download the VAM Mobile App

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The mobile app for the 2018 Vascular Annual Meeting will be available Wednesday for both Apple and Android products. The app has been rebuilt from the ground up, for a very user-friendly experience. It’s interactive, comprehensive and searchable and includes many helpful features:

  • My Schedule: Mark sessions as favorites on either the Planner or app, then see all of them in the My Schedule section.
  • Educational Credits: Take self-assessment exams, via the app, and/or claim Continuing Medical Education credits.
  • Scavenger Hunt: Participate in the big game in the Exhibit Hall; using your app, scan QR codes found in the booths of sponsors, then answer the question that pops up. The three people who earn the most points for correct answers win great prizes.
  • Social Media – Let all your friends know what you’re up to by linking to social media

Download at Apple’s App Store and at Google Play.

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The mobile app for the 2018 Vascular Annual Meeting will be available Wednesday for both Apple and Android products. The app has been rebuilt from the ground up, for a very user-friendly experience. It’s interactive, comprehensive and searchable and includes many helpful features:

  • My Schedule: Mark sessions as favorites on either the Planner or app, then see all of them in the My Schedule section.
  • Educational Credits: Take self-assessment exams, via the app, and/or claim Continuing Medical Education credits.
  • Scavenger Hunt: Participate in the big game in the Exhibit Hall; using your app, scan QR codes found in the booths of sponsors, then answer the question that pops up. The three people who earn the most points for correct answers win great prizes.
  • Social Media – Let all your friends know what you’re up to by linking to social media

Download at Apple’s App Store and at Google Play.

The mobile app for the 2018 Vascular Annual Meeting will be available Wednesday for both Apple and Android products. The app has been rebuilt from the ground up, for a very user-friendly experience. It’s interactive, comprehensive and searchable and includes many helpful features:

  • My Schedule: Mark sessions as favorites on either the Planner or app, then see all of them in the My Schedule section.
  • Educational Credits: Take self-assessment exams, via the app, and/or claim Continuing Medical Education credits.
  • Scavenger Hunt: Participate in the big game in the Exhibit Hall; using your app, scan QR codes found in the booths of sponsors, then answer the question that pops up. The three people who earn the most points for correct answers win great prizes.
  • Social Media – Let all your friends know what you’re up to by linking to social media

Download at Apple’s App Store and at Google Play.

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VAM is Next Week – Are you Registered?

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Don’t miss the vascular surgery world’s headline event! Join colleagues and friends in Boston for this year’s Vascular Annual Meeting, June 20 to 23. Scientific sessions are June 21-23 and the Exhibit Hall is open June 21 to 22. Click here to register. To get a full schedule and begin creating your own personal agenda, complete with marking sessions as favorites, see the VAM Planner.

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Don’t miss the vascular surgery world’s headline event! Join colleagues and friends in Boston for this year’s Vascular Annual Meeting, June 20 to 23. Scientific sessions are June 21-23 and the Exhibit Hall is open June 21 to 22. Click here to register. To get a full schedule and begin creating your own personal agenda, complete with marking sessions as favorites, see the VAM Planner.

Don’t miss the vascular surgery world’s headline event! Join colleagues and friends in Boston for this year’s Vascular Annual Meeting, June 20 to 23. Scientific sessions are June 21-23 and the Exhibit Hall is open June 21 to 22. Click here to register. To get a full schedule and begin creating your own personal agenda, complete with marking sessions as favorites, see the VAM Planner.

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NAMDRC Legislative and Regulatory Agenda Once Again Focuses on Patient Access

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NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.


Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

 

 



Home Oxygen Therapy: In 1986, Congress revamped the statute governing coverage and payment of home oxygen. Pondering the reality of a segment of pulmonary medicine that has seen dramatic technological improvements and enhancements over the past 30-plus years, coupled with a payment system that is stuck with e-cylinders and competitive bidding, it is no wonder that both patients and physicians experience ongoing frustration trying to match a patient’s needs with an oxygen system that reflects the patient’s needs.

It’s a challenge to even consider where to start a reasonable discussion of home oxygen therapy. While the concept of supplemental oxygen is well accepted, the actual clinical evidence relies heavily on a very small number of studies. While virtually no one challenges the concept of the therapy, the actual science has progressed modestly in 30-plus years. But the technology surrounding oxygen therapy has become an industry all to itself. There are concentrators, portable oxygen concentrators, liquid systems, transfill systems, transtracheal oxygen therapy, and so on.

Add to the environment the growing demand for high flow systems that would deliver continuous flow oxygen at rates in excess of 4 L/min, and you begin to realize that the current payment system is a barrier to access. After all, the current payment system has problematic characteristics:

1. A flawed competitive bidding methodology;

2. Payment tied to liter flow pegged at a baseline of 2 L/min, regardless of actual patient need;

3. The major shift from a “delivery model” of care to a nondelivery model that reflects these newer technologies;

4. Virtual disappearance of liquid system availability as an option for physicians/patients;

5. The total failure of CMS to monitor, let alone act on, patient concerns.

Again, taking the NAMDRC Mission Statement into context, NAMDRC is working with all the key societies to craft a broad strategy to address these problems, acknowledging that it will likely take a mix of legislative and regulatory actions to bring home oxygen therapy into the 21st century, let alone to reflect realities of care in 2018.
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NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.


Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

 

 



Home Oxygen Therapy: In 1986, Congress revamped the statute governing coverage and payment of home oxygen. Pondering the reality of a segment of pulmonary medicine that has seen dramatic technological improvements and enhancements over the past 30-plus years, coupled with a payment system that is stuck with e-cylinders and competitive bidding, it is no wonder that both patients and physicians experience ongoing frustration trying to match a patient’s needs with an oxygen system that reflects the patient’s needs.

It’s a challenge to even consider where to start a reasonable discussion of home oxygen therapy. While the concept of supplemental oxygen is well accepted, the actual clinical evidence relies heavily on a very small number of studies. While virtually no one challenges the concept of the therapy, the actual science has progressed modestly in 30-plus years. But the technology surrounding oxygen therapy has become an industry all to itself. There are concentrators, portable oxygen concentrators, liquid systems, transfill systems, transtracheal oxygen therapy, and so on.

Add to the environment the growing demand for high flow systems that would deliver continuous flow oxygen at rates in excess of 4 L/min, and you begin to realize that the current payment system is a barrier to access. After all, the current payment system has problematic characteristics:

1. A flawed competitive bidding methodology;

2. Payment tied to liter flow pegged at a baseline of 2 L/min, regardless of actual patient need;

3. The major shift from a “delivery model” of care to a nondelivery model that reflects these newer technologies;

4. Virtual disappearance of liquid system availability as an option for physicians/patients;

5. The total failure of CMS to monitor, let alone act on, patient concerns.

Again, taking the NAMDRC Mission Statement into context, NAMDRC is working with all the key societies to craft a broad strategy to address these problems, acknowledging that it will likely take a mix of legislative and regulatory actions to bring home oxygen therapy into the 21st century, let alone to reflect realities of care in 2018.

 

NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.


Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

 

 



Home Oxygen Therapy: In 1986, Congress revamped the statute governing coverage and payment of home oxygen. Pondering the reality of a segment of pulmonary medicine that has seen dramatic technological improvements and enhancements over the past 30-plus years, coupled with a payment system that is stuck with e-cylinders and competitive bidding, it is no wonder that both patients and physicians experience ongoing frustration trying to match a patient’s needs with an oxygen system that reflects the patient’s needs.

It’s a challenge to even consider where to start a reasonable discussion of home oxygen therapy. While the concept of supplemental oxygen is well accepted, the actual clinical evidence relies heavily on a very small number of studies. While virtually no one challenges the concept of the therapy, the actual science has progressed modestly in 30-plus years. But the technology surrounding oxygen therapy has become an industry all to itself. There are concentrators, portable oxygen concentrators, liquid systems, transfill systems, transtracheal oxygen therapy, and so on.

Add to the environment the growing demand for high flow systems that would deliver continuous flow oxygen at rates in excess of 4 L/min, and you begin to realize that the current payment system is a barrier to access. After all, the current payment system has problematic characteristics:

1. A flawed competitive bidding methodology;

2. Payment tied to liter flow pegged at a baseline of 2 L/min, regardless of actual patient need;

3. The major shift from a “delivery model” of care to a nondelivery model that reflects these newer technologies;

4. Virtual disappearance of liquid system availability as an option for physicians/patients;

5. The total failure of CMS to monitor, let alone act on, patient concerns.

Again, taking the NAMDRC Mission Statement into context, NAMDRC is working with all the key societies to craft a broad strategy to address these problems, acknowledging that it will likely take a mix of legislative and regulatory actions to bring home oxygen therapy into the 21st century, let alone to reflect realities of care in 2018.
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Looking for a research opportunity? Check our updated website for current programs in your area. If your institution has an opportunity to promote, let us know at [email protected].

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Looking for a research opportunity? Check our updated website for current programs in your area. If your institution has an opportunity to promote, let us know at [email protected].

Looking for a research opportunity? Check our updated website for current programs in your area. If your institution has an opportunity to promote, let us know at [email protected].

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The SVS is recruiting volunteers to serve on a new Task Force on the Future of Vascular Surgery, which will examine a number of critical trends shaping the specialty. President-elect Michael Makaroun, MD, will chair the new group. Learn more, including how to volunteer, here.

The SVS is recruiting volunteers to serve on a new Task Force on the Future of Vascular Surgery, which will examine a number of critical trends shaping the specialty. President-elect Michael Makaroun, MD, will chair the new group. Learn more, including how to volunteer, here.

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