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Texas medical board drops appeal against Teladoc
The Texas Medical Board (TMB) has dropped an appeal that had challenged whether national telemedicine company Teladoc could sue over telemedicine restrictions enacted by the board. Both parties will now prepare to argue the merits behind the case in U.S. District Court in Austin, Texas.
TMB plans to vigorously defend its telemedicine rules in court, said Scott Freshour, interim executive director. He did not elaborate on the reasons behind the board’s Oct. 14 vote to withdraw its appeal in the case.
TMB withdrew its appeal because it didn’t want to suffer another loss to Teladoc in the courts, said Adam Vandervoort, Teladoc’s chief legal counsel. In a public meeting, a TMB official called the decision to withdraw “purely strategic,” according to Mr. Vandervoort.
This “raises troubling questions about the TMB’s motives in both filing, and subsequently retracting, the appeal,” Mr. Vandervoort said in a statement. “Teladoc and its amicus parties expended substantial resources on defending the appeal, which now will not result in a decision.”
The dispute stems from a medical board rule that requires Texas physicians to conduct a “face-to-face” evaluation before treating a patient via telemedicine. The face-to-face visit can be conducted through telemedicine at an established medical site, but it may not be established through an online questionnaire, e-mail, text, chat, or telephonic evaluation or consultation. In addition, the TMB requires that distant site providers establish a physician-patient relationship, which at a minimum includes: establishing that the person requesting the treatment is in fact who the person claims to be, establishing a diagnosis through the use of acceptable medical practices, discussing with the patient the risks and benefits of various treatment options, and ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.
Teladoc sued the medical board in April 2015 claiming the face-to-face rule violates federal antitrust laws. Teladoc provides access to medical care via phone or interactive video and treats patients for nonemergency conditions. A judge halted the rule’s enforcement until the litigation is resolved.
The TMB requested that a judge throw out the suit, arguing that the board is immune from antitrust liability as a state agency. A district court disagreed and allowed the case to proceed. The board then appealed to 5th U.S. Circuit Court of Appeals to overturn the district court’s decision.
It’s likely that the board’s decision not to pursue the appeal was affected by the recent backing of Teladoc by the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) regarding the application of the state action doctrine, said Paul W. Pitts, a San Francisco health law attorney who has closely followed the case. The doctrine protects the deliberate policy choices of sovereign states to displace competition with regulation or monopoly public service.
In a brief to the 5th Circuit, the DOJ and the FTC urged the appeals court to dismiss the board’s appeal. The agencies called TMB’s telemedicine rules anticompetitive and said the board was not protected by the state action doctrine because requirements under the doctrine were not satisfied. However, the America Medical Association and the Texas Medical Association sided with the TMB, telling the court the entity should be immune from federal antitrust liability.
Aside from the AMA and Texas Medical Association, the Texas board had few allies in the appeals dispute,” Mr. Pitts said in an interview.
“Many interested parties were lining up on the side of Teledoc by filing amici curiae arguing that the 5th Circuit lacked jurisdiction to hear this appeal and that the state action doctrine is not applicable,” he said. “As the market for telemedicine grows rapidly, there is an increasing number of parties with something at stake in this case.”
Now that the appeal has ended, the district court can get back to the primary issue at hand: whether the rule requiring a face-to-face exam can be justified or whether it’s just a means of protecting the traditional physician practice, Mr. Pitts said. The ultimate ruling in the case has broad implications for the practice of telemedicine in Texas and beyond.
“Medical boards in other states are revising their rules to be more accommodating of telemedicine as the use of this approach grows in acceptance around the country.” he said. “The Texas Medical Board is increasingly an outlier in this space. If Teledoc prevails, you can expect to see investors taking another look at the telemedicine space as the Texas market opens up and the role of the state medical board is diminished.”
[email protected]
On Twitter @legal_med
The Texas Medical Board (TMB) has dropped an appeal that had challenged whether national telemedicine company Teladoc could sue over telemedicine restrictions enacted by the board. Both parties will now prepare to argue the merits behind the case in U.S. District Court in Austin, Texas.
TMB plans to vigorously defend its telemedicine rules in court, said Scott Freshour, interim executive director. He did not elaborate on the reasons behind the board’s Oct. 14 vote to withdraw its appeal in the case.
TMB withdrew its appeal because it didn’t want to suffer another loss to Teladoc in the courts, said Adam Vandervoort, Teladoc’s chief legal counsel. In a public meeting, a TMB official called the decision to withdraw “purely strategic,” according to Mr. Vandervoort.
This “raises troubling questions about the TMB’s motives in both filing, and subsequently retracting, the appeal,” Mr. Vandervoort said in a statement. “Teladoc and its amicus parties expended substantial resources on defending the appeal, which now will not result in a decision.”
The dispute stems from a medical board rule that requires Texas physicians to conduct a “face-to-face” evaluation before treating a patient via telemedicine. The face-to-face visit can be conducted through telemedicine at an established medical site, but it may not be established through an online questionnaire, e-mail, text, chat, or telephonic evaluation or consultation. In addition, the TMB requires that distant site providers establish a physician-patient relationship, which at a minimum includes: establishing that the person requesting the treatment is in fact who the person claims to be, establishing a diagnosis through the use of acceptable medical practices, discussing with the patient the risks and benefits of various treatment options, and ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.
Teladoc sued the medical board in April 2015 claiming the face-to-face rule violates federal antitrust laws. Teladoc provides access to medical care via phone or interactive video and treats patients for nonemergency conditions. A judge halted the rule’s enforcement until the litigation is resolved.
The TMB requested that a judge throw out the suit, arguing that the board is immune from antitrust liability as a state agency. A district court disagreed and allowed the case to proceed. The board then appealed to 5th U.S. Circuit Court of Appeals to overturn the district court’s decision.
It’s likely that the board’s decision not to pursue the appeal was affected by the recent backing of Teladoc by the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) regarding the application of the state action doctrine, said Paul W. Pitts, a San Francisco health law attorney who has closely followed the case. The doctrine protects the deliberate policy choices of sovereign states to displace competition with regulation or monopoly public service.
In a brief to the 5th Circuit, the DOJ and the FTC urged the appeals court to dismiss the board’s appeal. The agencies called TMB’s telemedicine rules anticompetitive and said the board was not protected by the state action doctrine because requirements under the doctrine were not satisfied. However, the America Medical Association and the Texas Medical Association sided with the TMB, telling the court the entity should be immune from federal antitrust liability.
Aside from the AMA and Texas Medical Association, the Texas board had few allies in the appeals dispute,” Mr. Pitts said in an interview.
“Many interested parties were lining up on the side of Teledoc by filing amici curiae arguing that the 5th Circuit lacked jurisdiction to hear this appeal and that the state action doctrine is not applicable,” he said. “As the market for telemedicine grows rapidly, there is an increasing number of parties with something at stake in this case.”
Now that the appeal has ended, the district court can get back to the primary issue at hand: whether the rule requiring a face-to-face exam can be justified or whether it’s just a means of protecting the traditional physician practice, Mr. Pitts said. The ultimate ruling in the case has broad implications for the practice of telemedicine in Texas and beyond.
“Medical boards in other states are revising their rules to be more accommodating of telemedicine as the use of this approach grows in acceptance around the country.” he said. “The Texas Medical Board is increasingly an outlier in this space. If Teledoc prevails, you can expect to see investors taking another look at the telemedicine space as the Texas market opens up and the role of the state medical board is diminished.”
[email protected]
On Twitter @legal_med
The Texas Medical Board (TMB) has dropped an appeal that had challenged whether national telemedicine company Teladoc could sue over telemedicine restrictions enacted by the board. Both parties will now prepare to argue the merits behind the case in U.S. District Court in Austin, Texas.
TMB plans to vigorously defend its telemedicine rules in court, said Scott Freshour, interim executive director. He did not elaborate on the reasons behind the board’s Oct. 14 vote to withdraw its appeal in the case.
TMB withdrew its appeal because it didn’t want to suffer another loss to Teladoc in the courts, said Adam Vandervoort, Teladoc’s chief legal counsel. In a public meeting, a TMB official called the decision to withdraw “purely strategic,” according to Mr. Vandervoort.
This “raises troubling questions about the TMB’s motives in both filing, and subsequently retracting, the appeal,” Mr. Vandervoort said in a statement. “Teladoc and its amicus parties expended substantial resources on defending the appeal, which now will not result in a decision.”
The dispute stems from a medical board rule that requires Texas physicians to conduct a “face-to-face” evaluation before treating a patient via telemedicine. The face-to-face visit can be conducted through telemedicine at an established medical site, but it may not be established through an online questionnaire, e-mail, text, chat, or telephonic evaluation or consultation. In addition, the TMB requires that distant site providers establish a physician-patient relationship, which at a minimum includes: establishing that the person requesting the treatment is in fact who the person claims to be, establishing a diagnosis through the use of acceptable medical practices, discussing with the patient the risks and benefits of various treatment options, and ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.
Teladoc sued the medical board in April 2015 claiming the face-to-face rule violates federal antitrust laws. Teladoc provides access to medical care via phone or interactive video and treats patients for nonemergency conditions. A judge halted the rule’s enforcement until the litigation is resolved.
The TMB requested that a judge throw out the suit, arguing that the board is immune from antitrust liability as a state agency. A district court disagreed and allowed the case to proceed. The board then appealed to 5th U.S. Circuit Court of Appeals to overturn the district court’s decision.
It’s likely that the board’s decision not to pursue the appeal was affected by the recent backing of Teladoc by the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) regarding the application of the state action doctrine, said Paul W. Pitts, a San Francisco health law attorney who has closely followed the case. The doctrine protects the deliberate policy choices of sovereign states to displace competition with regulation or monopoly public service.
In a brief to the 5th Circuit, the DOJ and the FTC urged the appeals court to dismiss the board’s appeal. The agencies called TMB’s telemedicine rules anticompetitive and said the board was not protected by the state action doctrine because requirements under the doctrine were not satisfied. However, the America Medical Association and the Texas Medical Association sided with the TMB, telling the court the entity should be immune from federal antitrust liability.
Aside from the AMA and Texas Medical Association, the Texas board had few allies in the appeals dispute,” Mr. Pitts said in an interview.
“Many interested parties were lining up on the side of Teledoc by filing amici curiae arguing that the 5th Circuit lacked jurisdiction to hear this appeal and that the state action doctrine is not applicable,” he said. “As the market for telemedicine grows rapidly, there is an increasing number of parties with something at stake in this case.”
Now that the appeal has ended, the district court can get back to the primary issue at hand: whether the rule requiring a face-to-face exam can be justified or whether it’s just a means of protecting the traditional physician practice, Mr. Pitts said. The ultimate ruling in the case has broad implications for the practice of telemedicine in Texas and beyond.
“Medical boards in other states are revising their rules to be more accommodating of telemedicine as the use of this approach grows in acceptance around the country.” he said. “The Texas Medical Board is increasingly an outlier in this space. If Teledoc prevails, you can expect to see investors taking another look at the telemedicine space as the Texas market opens up and the role of the state medical board is diminished.”
[email protected]
On Twitter @legal_med
Analysis: CMS expects no MACRA pay cut for most small practices
Most small practices will see no change in their Medicare payments or perhaps even a bonus for participating in MACRA’s new Quality Payment Program (QPP) beginning in 2017.
Contrary to the initial proposed regulations from the Centers for Medicare & Medicaid Services, analysis of the final regulations shows that 90% of practices with one to nine clinicians should see no impact or even a pay increase in 2019 if they start participating in QPP next year, according to an agency analysis. The only way to fare worse would be to completely opt out of the program.
The sea change is based on two modifications to the proposed rule, according to Walter Gorski, director of regulatory affairs at the American College of Physicians. The first is the new flexibility for QPP participation for 2017. In September, CMS announced that any level of participation in the Merit-Based Incentive Payment System (MIPS) – from reporting “some data” as a low-level test to full participation in an Advanced Alternative Payment Model – would result in no penalty or pay cut for physicians and other health care providers.
The second key is the higher threshold for exemption from reporting requirements. Under the proposed rule, providers who receive Medicare payments of more than $10,000 for 100 and see fewer Medicare patients had to participate; the final rule raises that to $30,000 or more or 100 or fewer Medicare patients. Mr. Gorski said this could result in 30% of physicians being exempt and therefore not having to face the penalties associated with the program.
In comparison, CMS expect 98.5% of practices with more than 100 clinicians to receive either a bonus payment or no bonus/penalty.
Most small practices will see no change in their Medicare payments or perhaps even a bonus for participating in MACRA’s new Quality Payment Program (QPP) beginning in 2017.
Contrary to the initial proposed regulations from the Centers for Medicare & Medicaid Services, analysis of the final regulations shows that 90% of practices with one to nine clinicians should see no impact or even a pay increase in 2019 if they start participating in QPP next year, according to an agency analysis. The only way to fare worse would be to completely opt out of the program.
The sea change is based on two modifications to the proposed rule, according to Walter Gorski, director of regulatory affairs at the American College of Physicians. The first is the new flexibility for QPP participation for 2017. In September, CMS announced that any level of participation in the Merit-Based Incentive Payment System (MIPS) – from reporting “some data” as a low-level test to full participation in an Advanced Alternative Payment Model – would result in no penalty or pay cut for physicians and other health care providers.
The second key is the higher threshold for exemption from reporting requirements. Under the proposed rule, providers who receive Medicare payments of more than $10,000 for 100 and see fewer Medicare patients had to participate; the final rule raises that to $30,000 or more or 100 or fewer Medicare patients. Mr. Gorski said this could result in 30% of physicians being exempt and therefore not having to face the penalties associated with the program.
In comparison, CMS expect 98.5% of practices with more than 100 clinicians to receive either a bonus payment or no bonus/penalty.
Most small practices will see no change in their Medicare payments or perhaps even a bonus for participating in MACRA’s new Quality Payment Program (QPP) beginning in 2017.
Contrary to the initial proposed regulations from the Centers for Medicare & Medicaid Services, analysis of the final regulations shows that 90% of practices with one to nine clinicians should see no impact or even a pay increase in 2019 if they start participating in QPP next year, according to an agency analysis. The only way to fare worse would be to completely opt out of the program.
The sea change is based on two modifications to the proposed rule, according to Walter Gorski, director of regulatory affairs at the American College of Physicians. The first is the new flexibility for QPP participation for 2017. In September, CMS announced that any level of participation in the Merit-Based Incentive Payment System (MIPS) – from reporting “some data” as a low-level test to full participation in an Advanced Alternative Payment Model – would result in no penalty or pay cut for physicians and other health care providers.
The second key is the higher threshold for exemption from reporting requirements. Under the proposed rule, providers who receive Medicare payments of more than $10,000 for 100 and see fewer Medicare patients had to participate; the final rule raises that to $30,000 or more or 100 or fewer Medicare patients. Mr. Gorski said this could result in 30% of physicians being exempt and therefore not having to face the penalties associated with the program.
In comparison, CMS expect 98.5% of practices with more than 100 clinicians to receive either a bonus payment or no bonus/penalty.
Access issues looming as more docs eye exit from clinical practice
Almost half (47.8%) of physicians surveyed are considering a change in how they practice medicine within the next 1-3 years, including cutting back on hours, retiring, switching to cash/concierge practice, working locum tenens, seeking a nonclinical health care job, seeking employment, or working part time.
That’s according to responses to the 2016 Survey of America’s Physicians Practice Patterns & Perspectives, a biennial survey commissioned by The Physicians Foundation and conducted by Merritt Hawkins. A total of 17,236 physicians responded to the survey.
The percentage looking to change is up from 43.6% in the 2014 survey, but down from the 50.2% of physicians who responded the same way in 2012.
Dr. Ray pointed to a number of findings in the survey that could be driving the growth in those looking to make a change.
“If you think about the last year, the clinical, administrative, and financial changes that have occurred have occurred at a whirlwind pace,” Dr. Ray said. “For instance, continued expansion of the Affordable Care Act has included as many as 20 million new people to the rolls at the same time we have a documented physician shortage where 80% of physicians say that they have all the patients that they can take care of. They are either at capacity or they are overextended.”
Other factors influencing physicians’ employment decisions include the transition to value-based payments under the Medicare Access and CHIP Reauthorization Act (MACRA), the transition to ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” he said. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Given the volume of change, it is no surprise that physician morale is low, Dr. Ray said. “One of the first things that jumps out is morale. The question was ‘what best describes your professional morale about your current feelings and the current state of the medical profession?’ and 54% were somewhat or very negative; 46% were positive/somewhat positive/very positive. The very negatives were twice what the very positives were,” he noted.
Inadequate time to deliver quality care also was cited.
“Only 14% [of respondents] said that they have all the time that they need to provide the highest standards of care; 86% said that their time was either always limited, often limited, or sometimes limited,” Dr. Ray said.
Dr. Ray highlighted another question that provides insight into physicians’ dissatisfaction with their practice environment.
The survey asked, “To what degree is patient care in your practice adversely impacted by external factors such as third party authorizations, treatment protocols, EHR design, etc.”
“The critical term here is ‘adversely impacted,’ not just influenced, but adversely impacted,” Dr. Ray said. “Only 2.3% said not at all; 10% total said either not at all or a little bit. The rest said either somewhat, a good deal, or a great deal. In fact, 72% said a good deal or a great deal.”
All of this is leading to physician burnout, he said.
“I think it all bounces back to interference with the doctor/patient relationship and the fact that [physicians] feel like there are distractions within the practice of medicine due to the regulatory environment,” he said “They are not allowed to make decisions like they want to make in the best interest of their patients based on their training and their studying and their special experience with that patient. It creates this barrier with this professional satisfaction that they want to receive from taking care of patients.”
Almost half (47.8%) of physicians surveyed are considering a change in how they practice medicine within the next 1-3 years, including cutting back on hours, retiring, switching to cash/concierge practice, working locum tenens, seeking a nonclinical health care job, seeking employment, or working part time.
That’s according to responses to the 2016 Survey of America’s Physicians Practice Patterns & Perspectives, a biennial survey commissioned by The Physicians Foundation and conducted by Merritt Hawkins. A total of 17,236 physicians responded to the survey.
The percentage looking to change is up from 43.6% in the 2014 survey, but down from the 50.2% of physicians who responded the same way in 2012.
Dr. Ray pointed to a number of findings in the survey that could be driving the growth in those looking to make a change.
“If you think about the last year, the clinical, administrative, and financial changes that have occurred have occurred at a whirlwind pace,” Dr. Ray said. “For instance, continued expansion of the Affordable Care Act has included as many as 20 million new people to the rolls at the same time we have a documented physician shortage where 80% of physicians say that they have all the patients that they can take care of. They are either at capacity or they are overextended.”
Other factors influencing physicians’ employment decisions include the transition to value-based payments under the Medicare Access and CHIP Reauthorization Act (MACRA), the transition to ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” he said. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Given the volume of change, it is no surprise that physician morale is low, Dr. Ray said. “One of the first things that jumps out is morale. The question was ‘what best describes your professional morale about your current feelings and the current state of the medical profession?’ and 54% were somewhat or very negative; 46% were positive/somewhat positive/very positive. The very negatives were twice what the very positives were,” he noted.
Inadequate time to deliver quality care also was cited.
“Only 14% [of respondents] said that they have all the time that they need to provide the highest standards of care; 86% said that their time was either always limited, often limited, or sometimes limited,” Dr. Ray said.
Dr. Ray highlighted another question that provides insight into physicians’ dissatisfaction with their practice environment.
The survey asked, “To what degree is patient care in your practice adversely impacted by external factors such as third party authorizations, treatment protocols, EHR design, etc.”
“The critical term here is ‘adversely impacted,’ not just influenced, but adversely impacted,” Dr. Ray said. “Only 2.3% said not at all; 10% total said either not at all or a little bit. The rest said either somewhat, a good deal, or a great deal. In fact, 72% said a good deal or a great deal.”
All of this is leading to physician burnout, he said.
“I think it all bounces back to interference with the doctor/patient relationship and the fact that [physicians] feel like there are distractions within the practice of medicine due to the regulatory environment,” he said “They are not allowed to make decisions like they want to make in the best interest of their patients based on their training and their studying and their special experience with that patient. It creates this barrier with this professional satisfaction that they want to receive from taking care of patients.”
Almost half (47.8%) of physicians surveyed are considering a change in how they practice medicine within the next 1-3 years, including cutting back on hours, retiring, switching to cash/concierge practice, working locum tenens, seeking a nonclinical health care job, seeking employment, or working part time.
That’s according to responses to the 2016 Survey of America’s Physicians Practice Patterns & Perspectives, a biennial survey commissioned by The Physicians Foundation and conducted by Merritt Hawkins. A total of 17,236 physicians responded to the survey.
The percentage looking to change is up from 43.6% in the 2014 survey, but down from the 50.2% of physicians who responded the same way in 2012.
Dr. Ray pointed to a number of findings in the survey that could be driving the growth in those looking to make a change.
“If you think about the last year, the clinical, administrative, and financial changes that have occurred have occurred at a whirlwind pace,” Dr. Ray said. “For instance, continued expansion of the Affordable Care Act has included as many as 20 million new people to the rolls at the same time we have a documented physician shortage where 80% of physicians say that they have all the patients that they can take care of. They are either at capacity or they are overextended.”
Other factors influencing physicians’ employment decisions include the transition to value-based payments under the Medicare Access and CHIP Reauthorization Act (MACRA), the transition to ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” he said. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Given the volume of change, it is no surprise that physician morale is low, Dr. Ray said. “One of the first things that jumps out is morale. The question was ‘what best describes your professional morale about your current feelings and the current state of the medical profession?’ and 54% were somewhat or very negative; 46% were positive/somewhat positive/very positive. The very negatives were twice what the very positives were,” he noted.
Inadequate time to deliver quality care also was cited.
“Only 14% [of respondents] said that they have all the time that they need to provide the highest standards of care; 86% said that their time was either always limited, often limited, or sometimes limited,” Dr. Ray said.
Dr. Ray highlighted another question that provides insight into physicians’ dissatisfaction with their practice environment.
The survey asked, “To what degree is patient care in your practice adversely impacted by external factors such as third party authorizations, treatment protocols, EHR design, etc.”
“The critical term here is ‘adversely impacted,’ not just influenced, but adversely impacted,” Dr. Ray said. “Only 2.3% said not at all; 10% total said either not at all or a little bit. The rest said either somewhat, a good deal, or a great deal. In fact, 72% said a good deal or a great deal.”
All of this is leading to physician burnout, he said.
“I think it all bounces back to interference with the doctor/patient relationship and the fact that [physicians] feel like there are distractions within the practice of medicine due to the regulatory environment,” he said “They are not allowed to make decisions like they want to make in the best interest of their patients based on their training and their studying and their special experience with that patient. It creates this barrier with this professional satisfaction that they want to receive from taking care of patients.”
CMS offering educational webinars on MACRA
The Centers for Medicare & Medicaid Services is offering a pair of webinars aimed at helping physicians navigate the new regulation that operationalizes the Medicare Access and CHIP Reauthorization Act (MACRA).
The first webinar, scheduled for Oct. 26, will provide an overview of the two components of the Quality Payment Program – the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs).
The second webinar, scheduled for Nov. 15, is targeted to Medicare Part B fee-for-service clinicians, office managers and administrators, state and national associations that represent health care providers, and other stakeholders and will feature a question-and-answer session.
The webinars are part of the agency’s ongoing efforts to help educate practitioners on the provisions of the final MACRA regulation, which was issued on Oct. 14. CMS also recently launched a website to help in that regard.
The Centers for Medicare & Medicaid Services is offering a pair of webinars aimed at helping physicians navigate the new regulation that operationalizes the Medicare Access and CHIP Reauthorization Act (MACRA).
The first webinar, scheduled for Oct. 26, will provide an overview of the two components of the Quality Payment Program – the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs).
The second webinar, scheduled for Nov. 15, is targeted to Medicare Part B fee-for-service clinicians, office managers and administrators, state and national associations that represent health care providers, and other stakeholders and will feature a question-and-answer session.
The webinars are part of the agency’s ongoing efforts to help educate practitioners on the provisions of the final MACRA regulation, which was issued on Oct. 14. CMS also recently launched a website to help in that regard.
The Centers for Medicare & Medicaid Services is offering a pair of webinars aimed at helping physicians navigate the new regulation that operationalizes the Medicare Access and CHIP Reauthorization Act (MACRA).
The first webinar, scheduled for Oct. 26, will provide an overview of the two components of the Quality Payment Program – the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs).
The second webinar, scheduled for Nov. 15, is targeted to Medicare Part B fee-for-service clinicians, office managers and administrators, state and national associations that represent health care providers, and other stakeholders and will feature a question-and-answer session.
The webinars are part of the agency’s ongoing efforts to help educate practitioners on the provisions of the final MACRA regulation, which was issued on Oct. 14. CMS also recently launched a website to help in that regard.
Enhanced recovery pathways in gynecology
Enhanced recovery surgical principles were first described in the 1990s.1 These principles postulate that the body’s stress response to surgical injury and deviation from normal physiology is the source of postoperative morbidity. Thus, enhanced recovery programs are designed around perioperative interventions that mitigate and help the body cope with the surgical stress response.
Many of these interventions run counter to traditional perioperative care paradigms. Enhanced recovery protocols are diverse but have common themes of avoiding preoperative fasting and bowel preparation, early oral intake, limiting use of drains and catheters, multimodal analgesia, early ambulation, and prioritizing euvolemia and normothermia. Individual interventions in these areas are combined to create a master protocol, which is implemented as a bundle to improve surgical outcomes.
Current components
Minimizing preoperative fasting, early postoperative refeeding, and preoperative carbohydrate-loading drinks are all key aspects of enhanced recovery protocols. “NPO after midnight” has been a longstanding rule due to the risk of aspiration with intubation. However, a Cochrane review found no evidence that a shortened period of fasting was associated with an increased risk of aspiration or related morbidity. Currently, the American Society of Anesthesiologists recommends only a 6-hour fast for solid foods and 2 hours for clear liquids.2,3
Preoperative fasting causes depletion of glycogen stores leading to insulin resistance and hyperglycemia, which are both associated with postoperative complications and morbidity.4 Preoperative carbohydrate-loading drinks can reverse some of the effects of limited preoperative fasting including preventing insulin resistance and hyperglycemia.5
Postoperative fasting should also be avoided. Early enteral intake is very important to decrease time spent in a catabolic state and decrease insulin resistance. In gynecology patients, early refeeding is associated with a faster return of bowel function and a decreased length of stay without an increase in postoperative complications.6 Notably, patients undergoing early feeding consistently experience more nausea and vomiting, but this is not associated with complications.7
The fluid management goal in enhanced recovery is to maintain perioperative euvolemia, as both hypovolemia and hypervolemia have negative physiologic consequences. When studied, fluid protocols designed to minimize the use of postoperative fluids have resulted in decreased cardiopulmonary complications, decreased postoperative morbidity, faster return of bowel function, and shorter hospital stays.8 Given the morbidity associated with fluid overload, enhanced recovery protocols recommend that minimal fluids be given in the operating room and intravenous fluids be removed as quickly as possible, often with first oral intake or postoperative day 1 at the latest.
Engagement of the patient in their perioperative recovery with patient education materials and expectations for postoperative tasks, such as early refeeding, spirometry, and ambulation are all important components of enhanced recovery. Patients become partners in achieving postoperative milestones, and this results in improved outcomes such as decreased pain scores and shorter recoveries.
Evidence in gynecology
Enhanced recovery has been studied in many surgical disciplines including urology, colorectal surgery, hepatobiliary surgery, and gynecology. High-quality studies of abdominal and vaginal hysterectomy patients have consistently found a decrease in length of stay with no difference in readmission or postoperative complication rates.9 An interesting study also found that an enhanced recovery program was associated with decreased nursing time required for patient care.10
For ovarian cancer patients, enhanced recovery is associated with decreased length of stay, decreased time to return of bowel function, and improved quality of life. Enhanced recovery is also cost saving, saving $257-$697 per vaginal hysterectomy patient and $5,410-$7,600 per ovarian cancer patient.11
Enhanced recovery protocols are safe, evidenced based, cost saving, and are increasingly being adopted as clinicians and health systems become aware of their benefits.
References
1. Br J Anaesth. 1997 May;78(5):606-17.
2. Cochrane Database Syst Rev. 2003 Oct 20;(4):CD004423.
3. Anesthesiology. 1999 Mar;90(3):896-905.
4. J Am Coll Surg. 2012 Jan;214(1):68-80.
5. Clin Nutr. 1998 Apr;17(2):65-71.
6. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD004508.
7. Obstet Gynecol. 1998 Jul;92(1):94-7.
8. Br J Surg. 2009 Apr;96(4):331-41.
9. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-28.
10. Qual Saf Health Care. 2009 Jun;18(3):236-40.
11. Gynecol Oncol. 2008 Feb;108(2):282-6.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Barber is a third-year fellow in gynecologic oncology at the university. They reported having no financial disclosures relevant to this column. Email them at [email protected].
Enhanced recovery surgical principles were first described in the 1990s.1 These principles postulate that the body’s stress response to surgical injury and deviation from normal physiology is the source of postoperative morbidity. Thus, enhanced recovery programs are designed around perioperative interventions that mitigate and help the body cope with the surgical stress response.
Many of these interventions run counter to traditional perioperative care paradigms. Enhanced recovery protocols are diverse but have common themes of avoiding preoperative fasting and bowel preparation, early oral intake, limiting use of drains and catheters, multimodal analgesia, early ambulation, and prioritizing euvolemia and normothermia. Individual interventions in these areas are combined to create a master protocol, which is implemented as a bundle to improve surgical outcomes.
Current components
Minimizing preoperative fasting, early postoperative refeeding, and preoperative carbohydrate-loading drinks are all key aspects of enhanced recovery protocols. “NPO after midnight” has been a longstanding rule due to the risk of aspiration with intubation. However, a Cochrane review found no evidence that a shortened period of fasting was associated with an increased risk of aspiration or related morbidity. Currently, the American Society of Anesthesiologists recommends only a 6-hour fast for solid foods and 2 hours for clear liquids.2,3
Preoperative fasting causes depletion of glycogen stores leading to insulin resistance and hyperglycemia, which are both associated with postoperative complications and morbidity.4 Preoperative carbohydrate-loading drinks can reverse some of the effects of limited preoperative fasting including preventing insulin resistance and hyperglycemia.5
Postoperative fasting should also be avoided. Early enteral intake is very important to decrease time spent in a catabolic state and decrease insulin resistance. In gynecology patients, early refeeding is associated with a faster return of bowel function and a decreased length of stay without an increase in postoperative complications.6 Notably, patients undergoing early feeding consistently experience more nausea and vomiting, but this is not associated with complications.7
The fluid management goal in enhanced recovery is to maintain perioperative euvolemia, as both hypovolemia and hypervolemia have negative physiologic consequences. When studied, fluid protocols designed to minimize the use of postoperative fluids have resulted in decreased cardiopulmonary complications, decreased postoperative morbidity, faster return of bowel function, and shorter hospital stays.8 Given the morbidity associated with fluid overload, enhanced recovery protocols recommend that minimal fluids be given in the operating room and intravenous fluids be removed as quickly as possible, often with first oral intake or postoperative day 1 at the latest.
Engagement of the patient in their perioperative recovery with patient education materials and expectations for postoperative tasks, such as early refeeding, spirometry, and ambulation are all important components of enhanced recovery. Patients become partners in achieving postoperative milestones, and this results in improved outcomes such as decreased pain scores and shorter recoveries.
Evidence in gynecology
Enhanced recovery has been studied in many surgical disciplines including urology, colorectal surgery, hepatobiliary surgery, and gynecology. High-quality studies of abdominal and vaginal hysterectomy patients have consistently found a decrease in length of stay with no difference in readmission or postoperative complication rates.9 An interesting study also found that an enhanced recovery program was associated with decreased nursing time required for patient care.10
For ovarian cancer patients, enhanced recovery is associated with decreased length of stay, decreased time to return of bowel function, and improved quality of life. Enhanced recovery is also cost saving, saving $257-$697 per vaginal hysterectomy patient and $5,410-$7,600 per ovarian cancer patient.11
Enhanced recovery protocols are safe, evidenced based, cost saving, and are increasingly being adopted as clinicians and health systems become aware of their benefits.
References
1. Br J Anaesth. 1997 May;78(5):606-17.
2. Cochrane Database Syst Rev. 2003 Oct 20;(4):CD004423.
3. Anesthesiology. 1999 Mar;90(3):896-905.
4. J Am Coll Surg. 2012 Jan;214(1):68-80.
5. Clin Nutr. 1998 Apr;17(2):65-71.
6. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD004508.
7. Obstet Gynecol. 1998 Jul;92(1):94-7.
8. Br J Surg. 2009 Apr;96(4):331-41.
9. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-28.
10. Qual Saf Health Care. 2009 Jun;18(3):236-40.
11. Gynecol Oncol. 2008 Feb;108(2):282-6.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Barber is a third-year fellow in gynecologic oncology at the university. They reported having no financial disclosures relevant to this column. Email them at [email protected].
Enhanced recovery surgical principles were first described in the 1990s.1 These principles postulate that the body’s stress response to surgical injury and deviation from normal physiology is the source of postoperative morbidity. Thus, enhanced recovery programs are designed around perioperative interventions that mitigate and help the body cope with the surgical stress response.
Many of these interventions run counter to traditional perioperative care paradigms. Enhanced recovery protocols are diverse but have common themes of avoiding preoperative fasting and bowel preparation, early oral intake, limiting use of drains and catheters, multimodal analgesia, early ambulation, and prioritizing euvolemia and normothermia. Individual interventions in these areas are combined to create a master protocol, which is implemented as a bundle to improve surgical outcomes.
Current components
Minimizing preoperative fasting, early postoperative refeeding, and preoperative carbohydrate-loading drinks are all key aspects of enhanced recovery protocols. “NPO after midnight” has been a longstanding rule due to the risk of aspiration with intubation. However, a Cochrane review found no evidence that a shortened period of fasting was associated with an increased risk of aspiration or related morbidity. Currently, the American Society of Anesthesiologists recommends only a 6-hour fast for solid foods and 2 hours for clear liquids.2,3
Preoperative fasting causes depletion of glycogen stores leading to insulin resistance and hyperglycemia, which are both associated with postoperative complications and morbidity.4 Preoperative carbohydrate-loading drinks can reverse some of the effects of limited preoperative fasting including preventing insulin resistance and hyperglycemia.5
Postoperative fasting should also be avoided. Early enteral intake is very important to decrease time spent in a catabolic state and decrease insulin resistance. In gynecology patients, early refeeding is associated with a faster return of bowel function and a decreased length of stay without an increase in postoperative complications.6 Notably, patients undergoing early feeding consistently experience more nausea and vomiting, but this is not associated with complications.7
The fluid management goal in enhanced recovery is to maintain perioperative euvolemia, as both hypovolemia and hypervolemia have negative physiologic consequences. When studied, fluid protocols designed to minimize the use of postoperative fluids have resulted in decreased cardiopulmonary complications, decreased postoperative morbidity, faster return of bowel function, and shorter hospital stays.8 Given the morbidity associated with fluid overload, enhanced recovery protocols recommend that minimal fluids be given in the operating room and intravenous fluids be removed as quickly as possible, often with first oral intake or postoperative day 1 at the latest.
Engagement of the patient in their perioperative recovery with patient education materials and expectations for postoperative tasks, such as early refeeding, spirometry, and ambulation are all important components of enhanced recovery. Patients become partners in achieving postoperative milestones, and this results in improved outcomes such as decreased pain scores and shorter recoveries.
Evidence in gynecology
Enhanced recovery has been studied in many surgical disciplines including urology, colorectal surgery, hepatobiliary surgery, and gynecology. High-quality studies of abdominal and vaginal hysterectomy patients have consistently found a decrease in length of stay with no difference in readmission or postoperative complication rates.9 An interesting study also found that an enhanced recovery program was associated with decreased nursing time required for patient care.10
For ovarian cancer patients, enhanced recovery is associated with decreased length of stay, decreased time to return of bowel function, and improved quality of life. Enhanced recovery is also cost saving, saving $257-$697 per vaginal hysterectomy patient and $5,410-$7,600 per ovarian cancer patient.11
Enhanced recovery protocols are safe, evidenced based, cost saving, and are increasingly being adopted as clinicians and health systems become aware of their benefits.
References
1. Br J Anaesth. 1997 May;78(5):606-17.
2. Cochrane Database Syst Rev. 2003 Oct 20;(4):CD004423.
3. Anesthesiology. 1999 Mar;90(3):896-905.
4. J Am Coll Surg. 2012 Jan;214(1):68-80.
5. Clin Nutr. 1998 Apr;17(2):65-71.
6. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD004508.
7. Obstet Gynecol. 1998 Jul;92(1):94-7.
8. Br J Surg. 2009 Apr;96(4):331-41.
9. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-28.
10. Qual Saf Health Care. 2009 Jun;18(3):236-40.
11. Gynecol Oncol. 2008 Feb;108(2):282-6.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Barber is a third-year fellow in gynecologic oncology at the university. They reported having no financial disclosures relevant to this column. Email them at [email protected].
Uninsured rate lowest in Massachusetts
Massachusetts had the nation’s lowest uninsured rate in 2015, and Texas had the highest, according to the personal finance website WalletHub.
Massachusetts’ uninsured rate of 2.8% was followed by Vermont at 3.8%, Hawaii at 4%, Minnesota at 4.5%, and Iowa at 5%, WalletHub reported.
Nevada, which was 44th overall in 2015, had the largest reduction (–10.3%) in its uninsured rate from 2010 to 2015. Oregon had the next-largest drop (10.1%) and Massachusetts had the smallest decrease at –1.6%, meaning that no state saw an increase over the 5-year period, the WalletHub report showed.
A quick run through some subgroups shows that Vermont had the lowest percentage of uninsured children (1%) and Alaska had the highest (10.6%), Massachusetts was lowest for whites (2.2%) and Hispanics (5.3%) while Mississippi was highest (10.9% white and 37.6% Hispanic). Hawaii had the lowest rate (3.8%) for blacks, and Montana had the highest (17.4%), WalletHub said.
Massachusetts had the nation’s lowest uninsured rate in 2015, and Texas had the highest, according to the personal finance website WalletHub.
Massachusetts’ uninsured rate of 2.8% was followed by Vermont at 3.8%, Hawaii at 4%, Minnesota at 4.5%, and Iowa at 5%, WalletHub reported.
Nevada, which was 44th overall in 2015, had the largest reduction (–10.3%) in its uninsured rate from 2010 to 2015. Oregon had the next-largest drop (10.1%) and Massachusetts had the smallest decrease at –1.6%, meaning that no state saw an increase over the 5-year period, the WalletHub report showed.
A quick run through some subgroups shows that Vermont had the lowest percentage of uninsured children (1%) and Alaska had the highest (10.6%), Massachusetts was lowest for whites (2.2%) and Hispanics (5.3%) while Mississippi was highest (10.9% white and 37.6% Hispanic). Hawaii had the lowest rate (3.8%) for blacks, and Montana had the highest (17.4%), WalletHub said.
Massachusetts had the nation’s lowest uninsured rate in 2015, and Texas had the highest, according to the personal finance website WalletHub.
Massachusetts’ uninsured rate of 2.8% was followed by Vermont at 3.8%, Hawaii at 4%, Minnesota at 4.5%, and Iowa at 5%, WalletHub reported.
Nevada, which was 44th overall in 2015, had the largest reduction (–10.3%) in its uninsured rate from 2010 to 2015. Oregon had the next-largest drop (10.1%) and Massachusetts had the smallest decrease at –1.6%, meaning that no state saw an increase over the 5-year period, the WalletHub report showed.
A quick run through some subgroups shows that Vermont had the lowest percentage of uninsured children (1%) and Alaska had the highest (10.6%), Massachusetts was lowest for whites (2.2%) and Hispanics (5.3%) while Mississippi was highest (10.9% white and 37.6% Hispanic). Hawaii had the lowest rate (3.8%) for blacks, and Montana had the highest (17.4%), WalletHub said.
Experts: Fewer opioids, more treatment laws mean nothing without better access to care
WASHINGTON – Pressure on physicians to prescribe fewer opioids could have unintended consequences in the absence of adequate access to treatment, according to experts.
“There is mixed evidence that, when medication-assisted treatment is lacking, there are higher rates of transition from prescription opioids to heroin,” Gary Tsai, MD, said during a presentation at the American Psychiatric Association’s Institute on Psychiatric Services.
“As we constrict our prescribing, we want to make sure that there is ready access to these interventions, so that those who are already dependent on opioids can transition to something safer,” said Dr. Tsai, medical director and science officer of Substance Abuse Prevention and Control, a division of Los Angeles County’s public health department.
Medication-assisted treatment (MAT) uses methadone, buprenorphine, or naltrexone in combination with appropriate behavioral and other other psychosocial therapies to help achieve opioid abstinence. Despite MAT’s well-established superiority to either pharmacotherapy or psychosocial interventions alone, the use of MAT has, in some cases, declined. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), MAT was used in 35% of heroin-related treatment admissions in 2002, compared with 28% in 2010.
Reasons for MAT’s difficult path to acceptance are manifold, ranging from lack of certified facilities to administer the medications to misunderstanding about how the medications work, Dr. Tsai said.
A law passed earlier this year and the issuance of a final federal rule that increases the legal patient load that certified MAT providers can treat annually were designed to expand access to MAT. These, however, are only partial solutions, according to Margaret Chaplin, MD, a psychiatrist and program director of Community Mental Health Affiliates in New Britain, Conn.
“Can you imagine if endocrinologists were the only doctors who were certified to prescribe insulin and that each of them was only limited to prescribing to 100 patients?” Dr. Chaplin said in an interview. The final rule brought the number from 100 to 275 patients per year that a certified addiction specialist can treat. This might expand access to care, but “it sends a message that either the people with [addiction] don’t deserve treatment or that they don’t have a legitimate illness,” said Dr. Chaplin, who also was a presenter at the meeting.
Viewing people with opioid addiction through a lens of moral failing only compounds the nation’s addiction crisis, Dr. Chaplin believes. “Not to say that a person with a substance use disorder doesn’t have a responsibility to take care of their illness, [but] our [leaders] haven’t been well educated on the scientific evidence that addiction is a brain disease.”
It is true that, until the Comprehensive Addiction and Recovery Act was signed into law over the summer, nurse practitioners and physician assistants could have prescribed controlled substances such as acetaminophen/oxycontin but not the far less dangerous – and potentially life-saving – partial opioid agonist buprenorphine. Under the new law, those health care professions now have the same buprenorphine prescribing rights as physicians.
New legislation does not guarantee access to treatment, however. “Funding for MAT programs varies throughout the states, and the availability of these medications on formularies often determines how readily accessible MAT interventions are,” said Dr. Tsai, who emphasized the role of collaboration in ensuring the laws take hold.
“Addiction specialists comprise a minority of the work force. To scale MAT up, we need to engage other prescribers from other systems, including those in primary care and mental health,” Dr. Tai said. To wit, the three primary MAT facilities in Los Angeles County offer learning collaboratives with primary care clinicians who want to incorporate these services into their practice, even if they are not certified addiction specialists themselves. This helps increase referrals to the treatment facilities, he explained.
Overcoming resistance to offering MAT ultimately will depend on educating leaders about the costs of not doing so, Dr. Tsai and Dr. Chaplin said.
“Our system has been slow to adopt a disease model of addiction,” Dr. Chaplin said. “Buprenorphine and methadone are life-saving medical treatments that are regulated in ways that you don’t see for any other medical condition.”
SAMHSA currently is requesting comments through Nov. 1, 2016, on what should be required of MAT providers under the new law.
Neither Dr. Tsai nor Dr. Chaplin had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
WASHINGTON – Pressure on physicians to prescribe fewer opioids could have unintended consequences in the absence of adequate access to treatment, according to experts.
“There is mixed evidence that, when medication-assisted treatment is lacking, there are higher rates of transition from prescription opioids to heroin,” Gary Tsai, MD, said during a presentation at the American Psychiatric Association’s Institute on Psychiatric Services.
“As we constrict our prescribing, we want to make sure that there is ready access to these interventions, so that those who are already dependent on opioids can transition to something safer,” said Dr. Tsai, medical director and science officer of Substance Abuse Prevention and Control, a division of Los Angeles County’s public health department.
Medication-assisted treatment (MAT) uses methadone, buprenorphine, or naltrexone in combination with appropriate behavioral and other other psychosocial therapies to help achieve opioid abstinence. Despite MAT’s well-established superiority to either pharmacotherapy or psychosocial interventions alone, the use of MAT has, in some cases, declined. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), MAT was used in 35% of heroin-related treatment admissions in 2002, compared with 28% in 2010.
Reasons for MAT’s difficult path to acceptance are manifold, ranging from lack of certified facilities to administer the medications to misunderstanding about how the medications work, Dr. Tsai said.
A law passed earlier this year and the issuance of a final federal rule that increases the legal patient load that certified MAT providers can treat annually were designed to expand access to MAT. These, however, are only partial solutions, according to Margaret Chaplin, MD, a psychiatrist and program director of Community Mental Health Affiliates in New Britain, Conn.
“Can you imagine if endocrinologists were the only doctors who were certified to prescribe insulin and that each of them was only limited to prescribing to 100 patients?” Dr. Chaplin said in an interview. The final rule brought the number from 100 to 275 patients per year that a certified addiction specialist can treat. This might expand access to care, but “it sends a message that either the people with [addiction] don’t deserve treatment or that they don’t have a legitimate illness,” said Dr. Chaplin, who also was a presenter at the meeting.
Viewing people with opioid addiction through a lens of moral failing only compounds the nation’s addiction crisis, Dr. Chaplin believes. “Not to say that a person with a substance use disorder doesn’t have a responsibility to take care of their illness, [but] our [leaders] haven’t been well educated on the scientific evidence that addiction is a brain disease.”
It is true that, until the Comprehensive Addiction and Recovery Act was signed into law over the summer, nurse practitioners and physician assistants could have prescribed controlled substances such as acetaminophen/oxycontin but not the far less dangerous – and potentially life-saving – partial opioid agonist buprenorphine. Under the new law, those health care professions now have the same buprenorphine prescribing rights as physicians.
New legislation does not guarantee access to treatment, however. “Funding for MAT programs varies throughout the states, and the availability of these medications on formularies often determines how readily accessible MAT interventions are,” said Dr. Tsai, who emphasized the role of collaboration in ensuring the laws take hold.
“Addiction specialists comprise a minority of the work force. To scale MAT up, we need to engage other prescribers from other systems, including those in primary care and mental health,” Dr. Tai said. To wit, the three primary MAT facilities in Los Angeles County offer learning collaboratives with primary care clinicians who want to incorporate these services into their practice, even if they are not certified addiction specialists themselves. This helps increase referrals to the treatment facilities, he explained.
Overcoming resistance to offering MAT ultimately will depend on educating leaders about the costs of not doing so, Dr. Tsai and Dr. Chaplin said.
“Our system has been slow to adopt a disease model of addiction,” Dr. Chaplin said. “Buprenorphine and methadone are life-saving medical treatments that are regulated in ways that you don’t see for any other medical condition.”
SAMHSA currently is requesting comments through Nov. 1, 2016, on what should be required of MAT providers under the new law.
Neither Dr. Tsai nor Dr. Chaplin had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
WASHINGTON – Pressure on physicians to prescribe fewer opioids could have unintended consequences in the absence of adequate access to treatment, according to experts.
“There is mixed evidence that, when medication-assisted treatment is lacking, there are higher rates of transition from prescription opioids to heroin,” Gary Tsai, MD, said during a presentation at the American Psychiatric Association’s Institute on Psychiatric Services.
“As we constrict our prescribing, we want to make sure that there is ready access to these interventions, so that those who are already dependent on opioids can transition to something safer,” said Dr. Tsai, medical director and science officer of Substance Abuse Prevention and Control, a division of Los Angeles County’s public health department.
Medication-assisted treatment (MAT) uses methadone, buprenorphine, or naltrexone in combination with appropriate behavioral and other other psychosocial therapies to help achieve opioid abstinence. Despite MAT’s well-established superiority to either pharmacotherapy or psychosocial interventions alone, the use of MAT has, in some cases, declined. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), MAT was used in 35% of heroin-related treatment admissions in 2002, compared with 28% in 2010.
Reasons for MAT’s difficult path to acceptance are manifold, ranging from lack of certified facilities to administer the medications to misunderstanding about how the medications work, Dr. Tsai said.
A law passed earlier this year and the issuance of a final federal rule that increases the legal patient load that certified MAT providers can treat annually were designed to expand access to MAT. These, however, are only partial solutions, according to Margaret Chaplin, MD, a psychiatrist and program director of Community Mental Health Affiliates in New Britain, Conn.
“Can you imagine if endocrinologists were the only doctors who were certified to prescribe insulin and that each of them was only limited to prescribing to 100 patients?” Dr. Chaplin said in an interview. The final rule brought the number from 100 to 275 patients per year that a certified addiction specialist can treat. This might expand access to care, but “it sends a message that either the people with [addiction] don’t deserve treatment or that they don’t have a legitimate illness,” said Dr. Chaplin, who also was a presenter at the meeting.
Viewing people with opioid addiction through a lens of moral failing only compounds the nation’s addiction crisis, Dr. Chaplin believes. “Not to say that a person with a substance use disorder doesn’t have a responsibility to take care of their illness, [but] our [leaders] haven’t been well educated on the scientific evidence that addiction is a brain disease.”
It is true that, until the Comprehensive Addiction and Recovery Act was signed into law over the summer, nurse practitioners and physician assistants could have prescribed controlled substances such as acetaminophen/oxycontin but not the far less dangerous – and potentially life-saving – partial opioid agonist buprenorphine. Under the new law, those health care professions now have the same buprenorphine prescribing rights as physicians.
New legislation does not guarantee access to treatment, however. “Funding for MAT programs varies throughout the states, and the availability of these medications on formularies often determines how readily accessible MAT interventions are,” said Dr. Tsai, who emphasized the role of collaboration in ensuring the laws take hold.
“Addiction specialists comprise a minority of the work force. To scale MAT up, we need to engage other prescribers from other systems, including those in primary care and mental health,” Dr. Tai said. To wit, the three primary MAT facilities in Los Angeles County offer learning collaboratives with primary care clinicians who want to incorporate these services into their practice, even if they are not certified addiction specialists themselves. This helps increase referrals to the treatment facilities, he explained.
Overcoming resistance to offering MAT ultimately will depend on educating leaders about the costs of not doing so, Dr. Tsai and Dr. Chaplin said.
“Our system has been slow to adopt a disease model of addiction,” Dr. Chaplin said. “Buprenorphine and methadone are life-saving medical treatments that are regulated in ways that you don’t see for any other medical condition.”
SAMHSA currently is requesting comments through Nov. 1, 2016, on what should be required of MAT providers under the new law.
Neither Dr. Tsai nor Dr. Chaplin had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM INSTITUTE ON PSYCHIATRIC SERVICES
SAVR for radiation-induced aortic stenosis has high late mortality
ROME – Radiation-induced aortic stenosis is associated with markedly worse long-term outcome after surgical aortic valve replacement than when the operation is performed in patients without a history of radiotherapy, Milind Y. Desai, MD, reported at the annual congress of the European Society of Cardiology.
Moreover, the Society of Thoracic Surgeons (STS) score isn’t good at risk-stratifying patients with radiation-induced aortic stenosis who are under consideration for surgical aortic valve replacement (SAVR).
Radiation-induced heart disease is a late complication of thoracic radiotherapy. It’s particularly common in patients who got radiation for lymphomas or breast cancer. It can affect any cardiac structure, including the myocardium, pericardium, valves, coronary arteries, and the conduction system.
Aortic stenosis is the most common valvular manifestation, present in roughly 80% of patients with radiation-induced heart disease. At the Cleveland Clinic, the average time from radiotherapy to development of radiation-induced aortic stenosis (RIAS) is about 20 years. The condition is characterized by thickening of the junction between the base of the anterior mitral leaflet and aortic root, known as the aortomitral curtain, Dr. Desai explained.
He presented a retrospective observational cohort study involving 172 patients who underwent SAVR for RIAS and an equal number of SAVR patients with no such history. The groups were matched by age, sex, aortic valve area, and type and timing of SAVR. Of note, the group with RIAS had a mean preoperative STS score of 11, and the control group averaged a similar score of 10.
The key finding: During a mean follow-up of 6 years, the all-cause mortality rate was a hefty 48% in patients with RIAS, compared with just 7% in matched controls. Only about 5% of deaths in the group with RIAS were from recurrent malignancy. The low figure is not surprising given the average 20-year lag between radiotherapy and development of radiation-induced heart disease.
“In our experience, most of these patients develop a recurrent pleural effusion and nasty cardiopulmonary issues that result in their death,” according to Dr. Desai.
In a multivariate Cox proportional hazards analysis, a history of chest radiation therapy was by far the strongest predictor of all-cause mortality, conferring an 8.5-fold increase in risk.
The only other statistically significant predictor of mortality during follow-up in multivariate analysis was a high STS score, with an associated weak albeit statistically significant 1.15-fold increased risk. A total of 30 of 78 (39%) RIAS patients with an STS score below 4 died during follow-up, compared with none of 91 controls.
Thirty-four of 92 (37%) RIAS patients under age 65 died during follow-up, whereas none of 83 control SAVR patients did so.
Having coronary artery bypass surgery or other cardiac surgery at the time of SAVR was not associated with significantly increased risk of mortality compared with solo SAVR.
In-hospital outcomes were consistently worse after SAVR in the RIAS group. Half of the RIAS patients experienced in-hospital atrial fibrillation and 29% developed persistent atrial fibrillation, compared with 30% and 24% of controls. About 22% of RIAS patients were readmitted within 3 months after surgery, as were only 8% of controls. In-hospital mortality occurred in 2% of SAVR patients with RIAS; none of the matched controls did.
Dr. Desai reported having no financial interests relative to this study.
ROME – Radiation-induced aortic stenosis is associated with markedly worse long-term outcome after surgical aortic valve replacement than when the operation is performed in patients without a history of radiotherapy, Milind Y. Desai, MD, reported at the annual congress of the European Society of Cardiology.
Moreover, the Society of Thoracic Surgeons (STS) score isn’t good at risk-stratifying patients with radiation-induced aortic stenosis who are under consideration for surgical aortic valve replacement (SAVR).
Radiation-induced heart disease is a late complication of thoracic radiotherapy. It’s particularly common in patients who got radiation for lymphomas or breast cancer. It can affect any cardiac structure, including the myocardium, pericardium, valves, coronary arteries, and the conduction system.
Aortic stenosis is the most common valvular manifestation, present in roughly 80% of patients with radiation-induced heart disease. At the Cleveland Clinic, the average time from radiotherapy to development of radiation-induced aortic stenosis (RIAS) is about 20 years. The condition is characterized by thickening of the junction between the base of the anterior mitral leaflet and aortic root, known as the aortomitral curtain, Dr. Desai explained.
He presented a retrospective observational cohort study involving 172 patients who underwent SAVR for RIAS and an equal number of SAVR patients with no such history. The groups were matched by age, sex, aortic valve area, and type and timing of SAVR. Of note, the group with RIAS had a mean preoperative STS score of 11, and the control group averaged a similar score of 10.
The key finding: During a mean follow-up of 6 years, the all-cause mortality rate was a hefty 48% in patients with RIAS, compared with just 7% in matched controls. Only about 5% of deaths in the group with RIAS were from recurrent malignancy. The low figure is not surprising given the average 20-year lag between radiotherapy and development of radiation-induced heart disease.
“In our experience, most of these patients develop a recurrent pleural effusion and nasty cardiopulmonary issues that result in their death,” according to Dr. Desai.
In a multivariate Cox proportional hazards analysis, a history of chest radiation therapy was by far the strongest predictor of all-cause mortality, conferring an 8.5-fold increase in risk.
The only other statistically significant predictor of mortality during follow-up in multivariate analysis was a high STS score, with an associated weak albeit statistically significant 1.15-fold increased risk. A total of 30 of 78 (39%) RIAS patients with an STS score below 4 died during follow-up, compared with none of 91 controls.
Thirty-four of 92 (37%) RIAS patients under age 65 died during follow-up, whereas none of 83 control SAVR patients did so.
Having coronary artery bypass surgery or other cardiac surgery at the time of SAVR was not associated with significantly increased risk of mortality compared with solo SAVR.
In-hospital outcomes were consistently worse after SAVR in the RIAS group. Half of the RIAS patients experienced in-hospital atrial fibrillation and 29% developed persistent atrial fibrillation, compared with 30% and 24% of controls. About 22% of RIAS patients were readmitted within 3 months after surgery, as were only 8% of controls. In-hospital mortality occurred in 2% of SAVR patients with RIAS; none of the matched controls did.
Dr. Desai reported having no financial interests relative to this study.
ROME – Radiation-induced aortic stenosis is associated with markedly worse long-term outcome after surgical aortic valve replacement than when the operation is performed in patients without a history of radiotherapy, Milind Y. Desai, MD, reported at the annual congress of the European Society of Cardiology.
Moreover, the Society of Thoracic Surgeons (STS) score isn’t good at risk-stratifying patients with radiation-induced aortic stenosis who are under consideration for surgical aortic valve replacement (SAVR).
Radiation-induced heart disease is a late complication of thoracic radiotherapy. It’s particularly common in patients who got radiation for lymphomas or breast cancer. It can affect any cardiac structure, including the myocardium, pericardium, valves, coronary arteries, and the conduction system.
Aortic stenosis is the most common valvular manifestation, present in roughly 80% of patients with radiation-induced heart disease. At the Cleveland Clinic, the average time from radiotherapy to development of radiation-induced aortic stenosis (RIAS) is about 20 years. The condition is characterized by thickening of the junction between the base of the anterior mitral leaflet and aortic root, known as the aortomitral curtain, Dr. Desai explained.
He presented a retrospective observational cohort study involving 172 patients who underwent SAVR for RIAS and an equal number of SAVR patients with no such history. The groups were matched by age, sex, aortic valve area, and type and timing of SAVR. Of note, the group with RIAS had a mean preoperative STS score of 11, and the control group averaged a similar score of 10.
The key finding: During a mean follow-up of 6 years, the all-cause mortality rate was a hefty 48% in patients with RIAS, compared with just 7% in matched controls. Only about 5% of deaths in the group with RIAS were from recurrent malignancy. The low figure is not surprising given the average 20-year lag between radiotherapy and development of radiation-induced heart disease.
“In our experience, most of these patients develop a recurrent pleural effusion and nasty cardiopulmonary issues that result in their death,” according to Dr. Desai.
In a multivariate Cox proportional hazards analysis, a history of chest radiation therapy was by far the strongest predictor of all-cause mortality, conferring an 8.5-fold increase in risk.
The only other statistically significant predictor of mortality during follow-up in multivariate analysis was a high STS score, with an associated weak albeit statistically significant 1.15-fold increased risk. A total of 30 of 78 (39%) RIAS patients with an STS score below 4 died during follow-up, compared with none of 91 controls.
Thirty-four of 92 (37%) RIAS patients under age 65 died during follow-up, whereas none of 83 control SAVR patients did so.
Having coronary artery bypass surgery or other cardiac surgery at the time of SAVR was not associated with significantly increased risk of mortality compared with solo SAVR.
In-hospital outcomes were consistently worse after SAVR in the RIAS group. Half of the RIAS patients experienced in-hospital atrial fibrillation and 29% developed persistent atrial fibrillation, compared with 30% and 24% of controls. About 22% of RIAS patients were readmitted within 3 months after surgery, as were only 8% of controls. In-hospital mortality occurred in 2% of SAVR patients with RIAS; none of the matched controls did.
Dr. Desai reported having no financial interests relative to this study.
AT THE ESC CONGRESS 2016
Key clinical point:
Major finding: All-cause mortality occurred in 48% of 172 patients with radiation-induced severe aortic stenosis during a mean follow-up of 6 years after surgical aortic valve replacement, compared with just 7% of matched controls.
Data source: This was a retrospective observational study involving 172 closely matched pairs of surgical aortic valve replacement patients.
Disclosures: The presenter reported having no financial conflicts of interest regarding this study.
Frailty stratifies pediatric liver disease severity
MONTREAL – A newly devised measurement of frailty in children effectively determined the severity of liver disease in pediatric patients and might serve as a useful, independent predictor of outcomes following liver transplantations in children and adolescents.
The adapted pediatric frailty assessment formula is a “very valid, feasible, and valuable tool” for assessing children with chronic liver disease, Eberhard Lurz, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology and Nutrition. “Frailty captures an additional marker of ill health that is independent of the MELD-Na [Model for End-Stage Liver Disease–Na] and PELD,” [Pediatric End-Stage Liver Disease] said Dr. Lurz, a pediatric gastroenterologist at the Hospital for Sick Children in Toronto.
The idea of frailty assessment of children with liver disease sprang from a 2014 report that showed a five-item frailty index could predict mortality in adults with liver disease who were listed for liver transplantation and that this predictive power was independent of the patients’ MELD scores (Am J Transplant. 2014 Aug;14[8]:1870-9). That study used a five-item frailty index developed for adults (J Gerontol A Biol Sci Med Sci. 2001;56[3]:M146-57).
Dr. Lurz came up with a pediatric version of this frailty score using pediatric-oriented measures for each of the five items. To measure exhaustion he used the PedsQL (Pediatric Quality of Life Inventory) Multidimensional Fatigue Scale; for slowness he used a 6-minute walk test; for weakness he measured grip strength; for shrinkage he measured triceps skinfold thickness; and for diminished activity he used an age-appropriate physical activity questionnaire. He prespecified that a patient’s scores for each of these five measures are calculated by comparing their test results against age-specific norms. A patient with a value that fell more than one standard deviation below the normal range scores one point for the item and those with values more than two standard deviations below the normal range score two points. Hence the maximum score for all five items is 10.
Researchers at the collaborating centers completed full assessments for 71 of 85 pediatric patients with chronic liver disease in their clinics, and each full assessment took a median of 60 minutes. The patients ranged from 8-16 years old, with an average age of 13. The cohort included 36 patients with compensated chronic liver disease (CCLD) and 35 with end-stage liver disease (ESLD) who were listed for liver transplantation.
The median frailty score of the CCLD patients was 3 and the median score for those with ESLD was 5, a statistically significant difference that was largely driven by between-group differences in fatigue scores and physical activity scores. A receiver operating characteristic curve analysis by area under the curve showed that the frailty score accounted for 83% of the difference between patients with CCLD and ESLD, comparable to the distinguishing power of the MELD-Na score. Using a cutoff on the score of 6 or greater identified patients with ESLD with 47% sensitivity and 98% specificity, and this diagnostic capability was independent of a patient’s MELD-Na or PELD score.
The five elements that contribute to this pediatric frailty score could be the focus for targeted interventions to improve the outcomes of patients scheduled to undergo liver transplantation, Dr. Lurz said.
Dr. Lurz had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
MONTREAL – A newly devised measurement of frailty in children effectively determined the severity of liver disease in pediatric patients and might serve as a useful, independent predictor of outcomes following liver transplantations in children and adolescents.
The adapted pediatric frailty assessment formula is a “very valid, feasible, and valuable tool” for assessing children with chronic liver disease, Eberhard Lurz, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology and Nutrition. “Frailty captures an additional marker of ill health that is independent of the MELD-Na [Model for End-Stage Liver Disease–Na] and PELD,” [Pediatric End-Stage Liver Disease] said Dr. Lurz, a pediatric gastroenterologist at the Hospital for Sick Children in Toronto.
The idea of frailty assessment of children with liver disease sprang from a 2014 report that showed a five-item frailty index could predict mortality in adults with liver disease who were listed for liver transplantation and that this predictive power was independent of the patients’ MELD scores (Am J Transplant. 2014 Aug;14[8]:1870-9). That study used a five-item frailty index developed for adults (J Gerontol A Biol Sci Med Sci. 2001;56[3]:M146-57).
Dr. Lurz came up with a pediatric version of this frailty score using pediatric-oriented measures for each of the five items. To measure exhaustion he used the PedsQL (Pediatric Quality of Life Inventory) Multidimensional Fatigue Scale; for slowness he used a 6-minute walk test; for weakness he measured grip strength; for shrinkage he measured triceps skinfold thickness; and for diminished activity he used an age-appropriate physical activity questionnaire. He prespecified that a patient’s scores for each of these five measures are calculated by comparing their test results against age-specific norms. A patient with a value that fell more than one standard deviation below the normal range scores one point for the item and those with values more than two standard deviations below the normal range score two points. Hence the maximum score for all five items is 10.
Researchers at the collaborating centers completed full assessments for 71 of 85 pediatric patients with chronic liver disease in their clinics, and each full assessment took a median of 60 minutes. The patients ranged from 8-16 years old, with an average age of 13. The cohort included 36 patients with compensated chronic liver disease (CCLD) and 35 with end-stage liver disease (ESLD) who were listed for liver transplantation.
The median frailty score of the CCLD patients was 3 and the median score for those with ESLD was 5, a statistically significant difference that was largely driven by between-group differences in fatigue scores and physical activity scores. A receiver operating characteristic curve analysis by area under the curve showed that the frailty score accounted for 83% of the difference between patients with CCLD and ESLD, comparable to the distinguishing power of the MELD-Na score. Using a cutoff on the score of 6 or greater identified patients with ESLD with 47% sensitivity and 98% specificity, and this diagnostic capability was independent of a patient’s MELD-Na or PELD score.
The five elements that contribute to this pediatric frailty score could be the focus for targeted interventions to improve the outcomes of patients scheduled to undergo liver transplantation, Dr. Lurz said.
Dr. Lurz had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
MONTREAL – A newly devised measurement of frailty in children effectively determined the severity of liver disease in pediatric patients and might serve as a useful, independent predictor of outcomes following liver transplantations in children and adolescents.
The adapted pediatric frailty assessment formula is a “very valid, feasible, and valuable tool” for assessing children with chronic liver disease, Eberhard Lurz, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology and Nutrition. “Frailty captures an additional marker of ill health that is independent of the MELD-Na [Model for End-Stage Liver Disease–Na] and PELD,” [Pediatric End-Stage Liver Disease] said Dr. Lurz, a pediatric gastroenterologist at the Hospital for Sick Children in Toronto.
The idea of frailty assessment of children with liver disease sprang from a 2014 report that showed a five-item frailty index could predict mortality in adults with liver disease who were listed for liver transplantation and that this predictive power was independent of the patients’ MELD scores (Am J Transplant. 2014 Aug;14[8]:1870-9). That study used a five-item frailty index developed for adults (J Gerontol A Biol Sci Med Sci. 2001;56[3]:M146-57).
Dr. Lurz came up with a pediatric version of this frailty score using pediatric-oriented measures for each of the five items. To measure exhaustion he used the PedsQL (Pediatric Quality of Life Inventory) Multidimensional Fatigue Scale; for slowness he used a 6-minute walk test; for weakness he measured grip strength; for shrinkage he measured triceps skinfold thickness; and for diminished activity he used an age-appropriate physical activity questionnaire. He prespecified that a patient’s scores for each of these five measures are calculated by comparing their test results against age-specific norms. A patient with a value that fell more than one standard deviation below the normal range scores one point for the item and those with values more than two standard deviations below the normal range score two points. Hence the maximum score for all five items is 10.
Researchers at the collaborating centers completed full assessments for 71 of 85 pediatric patients with chronic liver disease in their clinics, and each full assessment took a median of 60 minutes. The patients ranged from 8-16 years old, with an average age of 13. The cohort included 36 patients with compensated chronic liver disease (CCLD) and 35 with end-stage liver disease (ESLD) who were listed for liver transplantation.
The median frailty score of the CCLD patients was 3 and the median score for those with ESLD was 5, a statistically significant difference that was largely driven by between-group differences in fatigue scores and physical activity scores. A receiver operating characteristic curve analysis by area under the curve showed that the frailty score accounted for 83% of the difference between patients with CCLD and ESLD, comparable to the distinguishing power of the MELD-Na score. Using a cutoff on the score of 6 or greater identified patients with ESLD with 47% sensitivity and 98% specificity, and this diagnostic capability was independent of a patient’s MELD-Na or PELD score.
The five elements that contribute to this pediatric frailty score could be the focus for targeted interventions to improve the outcomes of patients scheduled to undergo liver transplantation, Dr. Lurz said.
Dr. Lurz had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT WCPGHAN 2016
Key clinical point:
Major finding: The pediatric frailty score identified patients with end-stage liver disease with sensitivity of 47% and specificity of 98%.
Data source: A series of 71 pediatric patients with liver disease compiled from 17 U.S. and Canadian centers.
Disclosures: Dr. Lurz had no relevant financial disclosures.
VIDEO: Pre–gastric bypass antibiotics alter gut microbiome
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
EXPERT ANALYSIS FROM THE ACS CLINICAL CONGRESS
