Dear colleagues and friends,

Charles Kahi, MD, MS, AGAF, is a professor of medicine, Indiana University School of Medicine, Indianapolis. He is also an Associate Editor for GI & Hepatology News.

Yes

But, at a minimum, you should absolutely lean-in, listen, and learn.

The physician leadership team at Atlanta Gastroenterology Associates has been focused on developing strategies and partnerships that strengthen our ability to thrive in our marketplace while also fending off threats to our mission. The path to forming the managed services organization (MSO) United Digestive (UD) through our agreement with the private equity firm Frazier Healthcare Partners was arduous and required a significant investment of resources and time. Like at Atlanta Gastroenterology Associates, many influential leaders within our field, also supported by their physician partners, have concluded that the investment of a private equity firm to build an MSO led by professional business executives will reduce the administrative stresses looming over the traditional independent gastroenterologist business model. Now, and after almost 2 years as a member of UD, I unequivocally believe my ability to provide timely, high-quality, and affordable care to my community is currently more stable and in a stronger position for the future.

Like we did in deciding whether to establish a formal relationship with a private equity–backed platform group, here are some critical questions you should explore and answer:

-What advantages and disadvantages will being a part of a private equity–backed MSO group bring to our patients, our practice, our team, and our providers?

-What forces threaten our practice’s ability to remain viable and pertinent in both the near and long term? And, how can our group ward off these threats?

-There are many private equity firms interested in our practice as well as already established platform groups. How do we decide which is best?

-If remaining completely independent is not a sustainable long-term option, why not just become employed by a hospital, join a strategic partner, or form/join a multi-specialty group or accountable care organization (ACO)?

In the first 2 years, UD has answered many of the questions and executed on desired priorities. Our management team helped us to navigate the chaos of COVID, and UD still remains on target to meet many annual budget goals as well as end of the year financial targets. Processes and enhanced technologies like real-time dashboards provide immediate insight into all aspects of our business, allowing for more analytical decision-making. Our payor and vendor negotiations yielded stronger returns than anticipated leading to material earnings. The revamped patient services center improved clinic utilization rates, reduced patient call wait times, deployed an online patient scheduling option, and employed medical assistants for handling clinical phone matters.

Most importantly, not one change at UD has negatively affected our clinical autonomy and decision-making. The MSO and its management team has steered all medical-related issues to our chief medical officer and physician executive committee. Moreover, there was much less consternation amongst partners when the time arose for significant capital expenditures (i.e., upgrading our endoscopic equipment, instituting a new electronic health record and practice management system, or surviving the cash-flow crunch during the beginning of COVID), as our annual compensation was not affected.

A few broader points to consider that pertain to private equity activity in physician services (i.e., not specific to gastroenterology or UD):

• Private equity firms invest money in private companies with the expectation of superior financial returns. Their principals are searching for opportunities with significant upside and potential to generate the necessary earnings for such returns. In fragmented fields, there is potential to use MSO relationships to consolidate providers into a larger organization. Then, economies of scale will create benefits through sharing and saving costs, increased leverage in contract negotiations, and augmenting organic, de-novo growth through the addition of new lines of services. Make sure you understand the overall business strategy, how your addition impacts the overall MSO, and how you may personally benefit.
• It appears that many groups are overly-focused on the deal multiple, yet understanding the comprehensive value of a deal goes far beyond the multiple. A complete evaluation must also explore the principles of the compensation model, rollover equity, compounding interest, tax deferral strategies, utilization of debt, and potential earn-out terms. Experienced legal counsel can shed light on these issues.
• The timing in one’s professional career may cloud the perspective of whether partnering with a private equity group through an MSO is wise. However, I would argue the more important perspective is the judgement of the trajectory of your current practice versus adopting a new business model. If a practice can skillfully withstand the headwinds of the regulatory challenges, fierce competition for patient referrals from hospitals plus new provider entrants, and continued downward pressure from payors, then remaining independent may be reasonable. On the other hand, there is great value, security and protection of being within an organization with sizeable financial and experiential capital with like-minded colleagues.
• Many independent practices are also often approached by local and national hospitals. Relationships with hospitals are popular as they too offer professional management teams lessening administrative burdens, often secure referral networks and higher contractual rates for services rendered. Unlike with a PE deal, these partnerships may limit patient choice, almost inevitably increase patient cost, and do not include equity for the provider.

While there are many questions that need to be answered for each practice considering joining a PE backed MSO, what is clear from my experience is that there are enough benefits to such a partnership that it should be explored to understand how it might improve your ability to serve your patients and secure a long term “home” for your practice, providers, and employees.
 

Marc Sonenshine, MD, is a partner in United Digestive and the chairman of medicine at Northside Hospital, Atlanta.

A note of caution

Is private equity good for gastroenterology? The answer is not a definitive “yes” or “no”; it is “depends”. That said, private equity is here so you must understand the implications.

Private equity is an alternative investment strategy focused on assets not listed on a public exchange. Capital usually is derived from investors who can tolerate risk with the hope of a high return such as pension funds, university endowments, and high net-worth individuals. Capital is collected within a fund (or funds) managed by a professional team who invests in, or buys private companies using internal capital leveraged with debt (leveraged buy-out or LBO). Assets and governance both are sold to fund managers, who restructure operations, centralize or standardize workflows, acquire similar companies to achieve economies of scale, and eventually resell the new company to another entity (usually a larger private equity fund). Typically, the resale (second bite) occurs 5-7 years after initial acquisition and during that 5-7-year period, Private equity funds expect a substantial (10%-20%) annual return on investment resulting from revenue enhancement, new service lines, and overhead reduction.

Since 2016, private equity has actively courted GI practices and there now have been over 20 closed deals. Private equity fund managers have specific expertise in valuing GI practices, enhancing revenue, reducing overhead, collecting other regional (and sometimes distant) practices, centralizing operations, converting all practices to a single EMR, payer negotiations, and other practice functions, while leaving clinical care decisions to providers. Although this postacquisition scenario sounds attractive, there are downsides.

First, let’s review the upsides. As a mature partner in a highly valued practice, you could expect an acquisition payment in the range of $1 million (subject to capital gains tax). You receive a gross distribution based on a purchase multiple (9-12 times EBITA – a measure of your annual profit), minus investment in the new company, and annual payments to the Management Services Organization or MSO. Your income going forward will be reduced by annual obligations to the private equity fund, about 10%-40% of your production. Typically, a second sale occurs between 5 and 7 years after acquisition (yet to occur in GI), where the new company sells for another EBITA multiple (so it is in your financial interest to keep increasing practice value). Even with a modest EBITA multiple, you might net an amount that is double the initial acquisition payout. A senior partner could benefit financially in ways not readily available through other avenues of retirement.

Another benefit is access to capital to acquire more practices, bring new technology, improve facilities, integrate clinical and practice information, and weather reduced demand (like occurred with COVID-19). Independent practices are struggling to incorporate digital technologies that patients now expect, enhanced (and more expensive) endoscopes, new service lines, and the demand for real patient outcomes data during payer or health system negotiations.

So, what takes private equity from a clear “yes” to a “depends”? During COVID-19, physician incomes dropped substantially, since any revenue went first to pay bank debt, then fund fees, payment of overhead (leases, vendor commitments, residual staff), and finally to the doctors. A recent Medscape survey of 5,000 US physicians, revealed that 62% of MDs saw their income drop (23% by more than 50%). Physicians employed by health systems did not see nearly that income drop.

Once a practice is sold, physicians lose autonomy. When you are acquired by a private equity fund, the primary goal of the fund is a financial target. Long-term staff may be downsized, you may be asked to use equipment or supplies that are not to your standard, relationships with regional payers or health systems may become adversarial, productivity targets may alter your patient care decisions (more procedures, less external referrals), and relations with your partners may be strained (younger versus older).

A young physician who enters a private equity–acquired practice may work for decades at an income level discounted from preacquisition levels. They face a substantial buy-in if they hope to benefit from the second sale. Of course, one might argue that future salaries for all gastroenterologists will be reduced by increasing technology costs (endoscope companies are adding AI – can’t wait to see their pricing), reduced reimbursements, and increasing labor and supply costs. Serious threats to colonoscopy-based cancer screening are here, a development that makes future values of GI practices more tenuous. Finally, our payer mix will be worse than before COVID-19 because of long-term financial strains on the US economy.

We have to reflect on a similar practice acquisition trend that occurred in the 1990s, where practice management companies bought independent practices. While times are different now (for many reasons), all but one of those companies went bankrupt and the acquired practices had to rebuild from the ground up. Private equity funds that are heavily leveraged are especially vulnerable, as can be seen by current bankruptcies of large established companies (Hertz, Neiman-Marcus, and others).

Finally, we have to ask ourselves how patients will view your practice as more of us become acquired by financially driven partners. No matter how we paint private equity acquisitions, people understand that these funds are financially driven and practice sales are an income enhancement play for physicians. In 1986, Arnold Relman (Editor of the New England Journal of Medicine) gave two Tanner Lectures on human values at the University of Utah. He asked the following question:

“Is medical care a consumer good like any other, a commercial service provided by skilled vendors for consumers willing to pay the market price, or is there something fundamentally different about the relation between doctor and patient?”

I am not a Luddite, nor am I Don Quixote jousting at windmills. I do, however, want you to consider carefully before giving up on the traditional practice models that made our specialty what it is.
 

John I. Allen, MD, MBA, AGAF, is clinical professor of medicine, department of internal medicine, division of gastroenterology and hepatology, Institute for Healthcare Policy and Innovation, University School of Medicine, Chief Clinical Officer, University of Michigan Medical Group, Ann Arbor. He has no disclosures and takes full responsibility for the content.

Dear colleagues and friends,

Charles Kahi, MD, MS, AGAF, is a professor of medicine, Indiana University School of Medicine, Indianapolis. He is also an Associate Editor for GI & Hepatology News.

Yes

But, at a minimum, you should absolutely lean-in, listen, and learn.

The physician leadership team at Atlanta Gastroenterology Associates has been focused on developing strategies and partnerships that strengthen our ability to thrive in our marketplace while also fending off threats to our mission. The path to forming the managed services organization (MSO) United Digestive (UD) through our agreement with the private equity firm Frazier Healthcare Partners was arduous and required a significant investment of resources and time. Like at Atlanta Gastroenterology Associates, many influential leaders within our field, also supported by their physician partners, have concluded that the investment of a private equity firm to build an MSO led by professional business executives will reduce the administrative stresses looming over the traditional independent gastroenterologist business model. Now, and after almost 2 years as a member of UD, I unequivocally believe my ability to provide timely, high-quality, and affordable care to my community is currently more stable and in a stronger position for the future.

Like we did in deciding whether to establish a formal relationship with a private equity–backed platform group, here are some critical questions you should explore and answer:

-What advantages and disadvantages will being a part of a private equity–backed MSO group bring to our patients, our practice, our team, and our providers?

-What forces threaten our practice’s ability to remain viable and pertinent in both the near and long term? And, how can our group ward off these threats?

-There are many private equity firms interested in our practice as well as already established platform groups. How do we decide which is best?

-If remaining completely independent is not a sustainable long-term option, why not just become employed by a hospital, join a strategic partner, or form/join a multi-specialty group or accountable care organization (ACO)?

In the first 2 years, UD has answered many of the questions and executed on desired priorities. Our management team helped us to navigate the chaos of COVID, and UD still remains on target to meet many annual budget goals as well as end of the year financial targets. Processes and enhanced technologies like real-time dashboards provide immediate insight into all aspects of our business, allowing for more analytical decision-making. Our payor and vendor negotiations yielded stronger returns than anticipated leading to material earnings. The revamped patient services center improved clinic utilization rates, reduced patient call wait times, deployed an online patient scheduling option, and employed medical assistants for handling clinical phone matters.

Most importantly, not one change at UD has negatively affected our clinical autonomy and decision-making. The MSO and its management team has steered all medical-related issues to our chief medical officer and physician executive committee. Moreover, there was much less consternation amongst partners when the time arose for significant capital expenditures (i.e., upgrading our endoscopic equipment, instituting a new electronic health record and practice management system, or surviving the cash-flow crunch during the beginning of COVID), as our annual compensation was not affected.

A few broader points to consider that pertain to private equity activity in physician services (i.e., not specific to gastroenterology or UD):

• Private equity firms invest money in private companies with the expectation of superior financial returns. Their principals are searching for opportunities with significant upside and potential to generate the necessary earnings for such returns. In fragmented fields, there is potential to use MSO relationships to consolidate providers into a larger organization. Then, economies of scale will create benefits through sharing and saving costs, increased leverage in contract negotiations, and augmenting organic, de-novo growth through the addition of new lines of services. Make sure you understand the overall business strategy, how your addition impacts the overall MSO, and how you may personally benefit.
• It appears that many groups are overly-focused on the deal multiple, yet understanding the comprehensive value of a deal goes far beyond the multiple. A complete evaluation must also explore the principles of the compensation model, rollover equity, compounding interest, tax deferral strategies, utilization of debt, and potential earn-out terms. Experienced legal counsel can shed light on these issues.
• The timing in one’s professional career may cloud the perspective of whether partnering with a private equity group through an MSO is wise. However, I would argue the more important perspective is the judgement of the trajectory of your current practice versus adopting a new business model. If a practice can skillfully withstand the headwinds of the regulatory challenges, fierce competition for patient referrals from hospitals plus new provider entrants, and continued downward pressure from payors, then remaining independent may be reasonable. On the other hand, there is great value, security and protection of being within an organization with sizeable financial and experiential capital with like-minded colleagues.
• Many independent practices are also often approached by local and national hospitals. Relationships with hospitals are popular as they too offer professional management teams lessening administrative burdens, often secure referral networks and higher contractual rates for services rendered. Unlike with a PE deal, these partnerships may limit patient choice, almost inevitably increase patient cost, and do not include equity for the provider.

While there are many questions that need to be answered for each practice considering joining a PE backed MSO, what is clear from my experience is that there are enough benefits to such a partnership that it should be explored to understand how it might improve your ability to serve your patients and secure a long term “home” for your practice, providers, and employees.
 

Marc Sonenshine, MD, is a partner in United Digestive and the chairman of medicine at Northside Hospital, Atlanta.

A note of caution

Is private equity good for gastroenterology? The answer is not a definitive “yes” or “no”; it is “depends”. That said, private equity is here so you must understand the implications.

Private equity is an alternative investment strategy focused on assets not listed on a public exchange. Capital usually is derived from investors who can tolerate risk with the hope of a high return such as pension funds, university endowments, and high net-worth individuals. Capital is collected within a fund (or funds) managed by a professional team who invests in, or buys private companies using internal capital leveraged with debt (leveraged buy-out or LBO). Assets and governance both are sold to fund managers, who restructure operations, centralize or standardize workflows, acquire similar companies to achieve economies of scale, and eventually resell the new company to another entity (usually a larger private equity fund). Typically, the resale (second bite) occurs 5-7 years after initial acquisition and during that 5-7-year period, Private equity funds expect a substantial (10%-20%) annual return on investment resulting from revenue enhancement, new service lines, and overhead reduction.

Since 2016, private equity has actively courted GI practices and there now have been over 20 closed deals. Private equity fund managers have specific expertise in valuing GI practices, enhancing revenue, reducing overhead, collecting other regional (and sometimes distant) practices, centralizing operations, converting all practices to a single EMR, payer negotiations, and other practice functions, while leaving clinical care decisions to providers. Although this postacquisition scenario sounds attractive, there are downsides.

First, let’s review the upsides. As a mature partner in a highly valued practice, you could expect an acquisition payment in the range of $1 million (subject to capital gains tax). You receive a gross distribution based on a purchase multiple (9-12 times EBITA – a measure of your annual profit), minus investment in the new company, and annual payments to the Management Services Organization or MSO. Your income going forward will be reduced by annual obligations to the private equity fund, about 10%-40% of your production. Typically, a second sale occurs between 5 and 7 years after acquisition (yet to occur in GI), where the new company sells for another EBITA multiple (so it is in your financial interest to keep increasing practice value). Even with a modest EBITA multiple, you might net an amount that is double the initial acquisition payout. A senior partner could benefit financially in ways not readily available through other avenues of retirement.

Another benefit is access to capital to acquire more practices, bring new technology, improve facilities, integrate clinical and practice information, and weather reduced demand (like occurred with COVID-19). Independent practices are struggling to incorporate digital technologies that patients now expect, enhanced (and more expensive) endoscopes, new service lines, and the demand for real patient outcomes data during payer or health system negotiations.

So, what takes private equity from a clear “yes” to a “depends”? During COVID-19, physician incomes dropped substantially, since any revenue went first to pay bank debt, then fund fees, payment of overhead (leases, vendor commitments, residual staff), and finally to the doctors. A recent Medscape survey of 5,000 US physicians, revealed that 62% of MDs saw their income drop (23% by more than 50%). Physicians employed by health systems did not see nearly that income drop.

Once a practice is sold, physicians lose autonomy. When you are acquired by a private equity fund, the primary goal of the fund is a financial target. Long-term staff may be downsized, you may be asked to use equipment or supplies that are not to your standard, relationships with regional payers or health systems may become adversarial, productivity targets may alter your patient care decisions (more procedures, less external referrals), and relations with your partners may be strained (younger versus older).

A young physician who enters a private equity–acquired practice may work for decades at an income level discounted from preacquisition levels. They face a substantial buy-in if they hope to benefit from the second sale. Of course, one might argue that future salaries for all gastroenterologists will be reduced by increasing technology costs (endoscope companies are adding AI – can’t wait to see their pricing), reduced reimbursements, and increasing labor and supply costs. Serious threats to colonoscopy-based cancer screening are here, a development that makes future values of GI practices more tenuous. Finally, our payer mix will be worse than before COVID-19 because of long-term financial strains on the US economy.

We have to reflect on a similar practice acquisition trend that occurred in the 1990s, where practice management companies bought independent practices. While times are different now (for many reasons), all but one of those companies went bankrupt and the acquired practices had to rebuild from the ground up. Private equity funds that are heavily leveraged are especially vulnerable, as can be seen by current bankruptcies of large established companies (Hertz, Neiman-Marcus, and others).

Finally, we have to ask ourselves how patients will view your practice as more of us become acquired by financially driven partners. No matter how we paint private equity acquisitions, people understand that these funds are financially driven and practice sales are an income enhancement play for physicians. In 1986, Arnold Relman (Editor of the New England Journal of Medicine) gave two Tanner Lectures on human values at the University of Utah. He asked the following question:

“Is medical care a consumer good like any other, a commercial service provided by skilled vendors for consumers willing to pay the market price, or is there something fundamentally different about the relation between doctor and patient?”

I am not a Luddite, nor am I Don Quixote jousting at windmills. I do, however, want you to consider carefully before giving up on the traditional practice models that made our specialty what it is.
 

John I. Allen, MD, MBA, AGAF, is clinical professor of medicine, department of internal medicine, division of gastroenterology and hepatology, Institute for Healthcare Policy and Innovation, University School of Medicine, Chief Clinical Officer, University of Michigan Medical Group, Ann Arbor. He has no disclosures and takes full responsibility for the content.

Dear colleagues and friends,

Charles Kahi, MD, MS, AGAF, is a professor of medicine, Indiana University School of Medicine, Indianapolis. He is also an Associate Editor for GI & Hepatology News.

Yes

But, at a minimum, you should absolutely lean-in, listen, and learn.

The physician leadership team at Atlanta Gastroenterology Associates has been focused on developing strategies and partnerships that strengthen our ability to thrive in our marketplace while also fending off threats to our mission. The path to forming the managed services organization (MSO) United Digestive (UD) through our agreement with the private equity firm Frazier Healthcare Partners was arduous and required a significant investment of resources and time. Like at Atlanta Gastroenterology Associates, many influential leaders within our field, also supported by their physician partners, have concluded that the investment of a private equity firm to build an MSO led by professional business executives will reduce the administrative stresses looming over the traditional independent gastroenterologist business model. Now, and after almost 2 years as a member of UD, I unequivocally believe my ability to provide timely, high-quality, and affordable care to my community is currently more stable and in a stronger position for the future.

Like we did in deciding whether to establish a formal relationship with a private equity–backed platform group, here are some critical questions you should explore and answer:

-What advantages and disadvantages will being a part of a private equity–backed MSO group bring to our patients, our practice, our team, and our providers?

-What forces threaten our practice’s ability to remain viable and pertinent in both the near and long term? And, how can our group ward off these threats?

-There are many private equity firms interested in our practice as well as already established platform groups. How do we decide which is best?

-If remaining completely independent is not a sustainable long-term option, why not just become employed by a hospital, join a strategic partner, or form/join a multi-specialty group or accountable care organization (ACO)?

In the first 2 years, UD has answered many of the questions and executed on desired priorities. Our management team helped us to navigate the chaos of COVID, and UD still remains on target to meet many annual budget goals as well as end of the year financial targets. Processes and enhanced technologies like real-time dashboards provide immediate insight into all aspects of our business, allowing for more analytical decision-making. Our payor and vendor negotiations yielded stronger returns than anticipated leading to material earnings. The revamped patient services center improved clinic utilization rates, reduced patient call wait times, deployed an online patient scheduling option, and employed medical assistants for handling clinical phone matters.

Most importantly, not one change at UD has negatively affected our clinical autonomy and decision-making. The MSO and its management team has steered all medical-related issues to our chief medical officer and physician executive committee. Moreover, there was much less consternation amongst partners when the time arose for significant capital expenditures (i.e., upgrading our endoscopic equipment, instituting a new electronic health record and practice management system, or surviving the cash-flow crunch during the beginning of COVID), as our annual compensation was not affected.

A few broader points to consider that pertain to private equity activity in physician services (i.e., not specific to gastroenterology or UD):

• Private equity firms invest money in private companies with the expectation of superior financial returns. Their principals are searching for opportunities with significant upside and potential to generate the necessary earnings for such returns. In fragmented fields, there is potential to use MSO relationships to consolidate providers into a larger organization. Then, economies of scale will create benefits through sharing and saving costs, increased leverage in contract negotiations, and augmenting organic, de-novo growth through the addition of new lines of services. Make sure you understand the overall business strategy, how your addition impacts the overall MSO, and how you may personally benefit.
• It appears that many groups are overly-focused on the deal multiple, yet understanding the comprehensive value of a deal goes far beyond the multiple. A complete evaluation must also explore the principles of the compensation model, rollover equity, compounding interest, tax deferral strategies, utilization of debt, and potential earn-out terms. Experienced legal counsel can shed light on these issues.
• The timing in one’s professional career may cloud the perspective of whether partnering with a private equity group through an MSO is wise. However, I would argue the more important perspective is the judgement of the trajectory of your current practice versus adopting a new business model. If a practice can skillfully withstand the headwinds of the regulatory challenges, fierce competition for patient referrals from hospitals plus new provider entrants, and continued downward pressure from payors, then remaining independent may be reasonable. On the other hand, there is great value, security and protection of being within an organization with sizeable financial and experiential capital with like-minded colleagues.
• Many independent practices are also often approached by local and national hospitals. Relationships with hospitals are popular as they too offer professional management teams lessening administrative burdens, often secure referral networks and higher contractual rates for services rendered. Unlike with a PE deal, these partnerships may limit patient choice, almost inevitably increase patient cost, and do not include equity for the provider.

While there are many questions that need to be answered for each practice considering joining a PE backed MSO, what is clear from my experience is that there are enough benefits to such a partnership that it should be explored to understand how it might improve your ability to serve your patients and secure a long term “home” for your practice, providers, and employees.
 

Marc Sonenshine, MD, is a partner in United Digestive and the chairman of medicine at Northside Hospital, Atlanta.

A note of caution

Is private equity good for gastroenterology? The answer is not a definitive “yes” or “no”; it is “depends”. That said, private equity is here so you must understand the implications.

Private equity is an alternative investment strategy focused on assets not listed on a public exchange. Capital usually is derived from investors who can tolerate risk with the hope of a high return such as pension funds, university endowments, and high net-worth individuals. Capital is collected within a fund (or funds) managed by a professional team who invests in, or buys private companies using internal capital leveraged with debt (leveraged buy-out or LBO). Assets and governance both are sold to fund managers, who restructure operations, centralize or standardize workflows, acquire similar companies to achieve economies of scale, and eventually resell the new company to another entity (usually a larger private equity fund). Typically, the resale (second bite) occurs 5-7 years after initial acquisition and during that 5-7-year period, Private equity funds expect a substantial (10%-20%) annual return on investment resulting from revenue enhancement, new service lines, and overhead reduction.

Since 2016, private equity has actively courted GI practices and there now have been over 20 closed deals. Private equity fund managers have specific expertise in valuing GI practices, enhancing revenue, reducing overhead, collecting other regional (and sometimes distant) practices, centralizing operations, converting all practices to a single EMR, payer negotiations, and other practice functions, while leaving clinical care decisions to providers. Although this postacquisition scenario sounds attractive, there are downsides.

First, let’s review the upsides. As a mature partner in a highly valued practice, you could expect an acquisition payment in the range of $1 million (subject to capital gains tax). You receive a gross distribution based on a purchase multiple (9-12 times EBITA – a measure of your annual profit), minus investment in the new company, and annual payments to the Management Services Organization or MSO. Your income going forward will be reduced by annual obligations to the private equity fund, about 10%-40% of your production. Typically, a second sale occurs between 5 and 7 years after acquisition (yet to occur in GI), where the new company sells for another EBITA multiple (so it is in your financial interest to keep increasing practice value). Even with a modest EBITA multiple, you might net an amount that is double the initial acquisition payout. A senior partner could benefit financially in ways not readily available through other avenues of retirement.

Another benefit is access to capital to acquire more practices, bring new technology, improve facilities, integrate clinical and practice information, and weather reduced demand (like occurred with COVID-19). Independent practices are struggling to incorporate digital technologies that patients now expect, enhanced (and more expensive) endoscopes, new service lines, and the demand for real patient outcomes data during payer or health system negotiations.

So, what takes private equity from a clear “yes” to a “depends”? During COVID-19, physician incomes dropped substantially, since any revenue went first to pay bank debt, then fund fees, payment of overhead (leases, vendor commitments, residual staff), and finally to the doctors. A recent Medscape survey of 5,000 US physicians, revealed that 62% of MDs saw their income drop (23% by more than 50%). Physicians employed by health systems did not see nearly that income drop.

Once a practice is sold, physicians lose autonomy. When you are acquired by a private equity fund, the primary goal of the fund is a financial target. Long-term staff may be downsized, you may be asked to use equipment or supplies that are not to your standard, relationships with regional payers or health systems may become adversarial, productivity targets may alter your patient care decisions (more procedures, less external referrals), and relations with your partners may be strained (younger versus older).

A young physician who enters a private equity–acquired practice may work for decades at an income level discounted from preacquisition levels. They face a substantial buy-in if they hope to benefit from the second sale. Of course, one might argue that future salaries for all gastroenterologists will be reduced by increasing technology costs (endoscope companies are adding AI – can’t wait to see their pricing), reduced reimbursements, and increasing labor and supply costs. Serious threats to colonoscopy-based cancer screening are here, a development that makes future values of GI practices more tenuous. Finally, our payer mix will be worse than before COVID-19 because of long-term financial strains on the US economy.

We have to reflect on a similar practice acquisition trend that occurred in the 1990s, where practice management companies bought independent practices. While times are different now (for many reasons), all but one of those companies went bankrupt and the acquired practices had to rebuild from the ground up. Private equity funds that are heavily leveraged are especially vulnerable, as can be seen by current bankruptcies of large established companies (Hertz, Neiman-Marcus, and others).

Finally, we have to ask ourselves how patients will view your practice as more of us become acquired by financially driven partners. No matter how we paint private equity acquisitions, people understand that these funds are financially driven and practice sales are an income enhancement play for physicians. In 1986, Arnold Relman (Editor of the New England Journal of Medicine) gave two Tanner Lectures on human values at the University of Utah. He asked the following question:

“Is medical care a consumer good like any other, a commercial service provided by skilled vendors for consumers willing to pay the market price, or is there something fundamentally different about the relation between doctor and patient?”

I am not a Luddite, nor am I Don Quixote jousting at windmills. I do, however, want you to consider carefully before giving up on the traditional practice models that made our specialty what it is.
 

John I. Allen, MD, MBA, AGAF, is clinical professor of medicine, department of internal medicine, division of gastroenterology and hepatology, Institute for Healthcare Policy and Innovation, University School of Medicine, Chief Clinical Officer, University of Michigan Medical Group, Ann Arbor. He has no disclosures and takes full responsibility for the content.

The AGA GI Patient Center has released a new brochure entitled “Biologic and biosimilar medicines: What you need to know.” The new brochure includes interactive elements like quizzes, medication sheets, symptom tracker, and the option of audibly listening to the pages.

The brochure provides patients with:

• An overview of the immune system.

• Background on immune-mediated conditions.

• Biologics and biosimilars: What are they?

• Information on biosimilars and generics.

• Cost of biologics and biosimilars.

• The importance of adhering to their treatment plan.

• Tips to start the conversation with their provider.

• Safety of biologics and biosimilars.

Share this new resource with your patients by printing, linking from your practice website, or emailing the link to your patients. Visit the AGA GI Patient Center page dedicated to biosimilars for more at gastro.org/biosimilars.

AGA members will also receive print copies of the new brochure this month. Order additional copies for your practice at http://www.agaresources.com/order_biosimilars.php. The brochure was reviewed by Jami Kinnucan, MD, and Rajeev Jain, MD, AGAF, AGA Patient Education Adviser.

View the interactive brochure at https://bit.ly/2JYE5tI.This brochure was funded by an independent medical education grant from Pfizer Inc.

ginews@gastro.org

The AGA GI Patient Center has released a new brochure entitled “Biologic and biosimilar medicines: What you need to know.” The new brochure includes interactive elements like quizzes, medication sheets, symptom tracker, and the option of audibly listening to the pages.

The brochure provides patients with:

• An overview of the immune system.

• Background on immune-mediated conditions.

• Biologics and biosimilars: What are they?

• Information on biosimilars and generics.

• Cost of biologics and biosimilars.

• The importance of adhering to their treatment plan.

• Tips to start the conversation with their provider.

• Safety of biologics and biosimilars.

Share this new resource with your patients by printing, linking from your practice website, or emailing the link to your patients. Visit the AGA GI Patient Center page dedicated to biosimilars for more at gastro.org/biosimilars.

AGA members will also receive print copies of the new brochure this month. Order additional copies for your practice at http://www.agaresources.com/order_biosimilars.php. The brochure was reviewed by Jami Kinnucan, MD, and Rajeev Jain, MD, AGAF, AGA Patient Education Adviser.

View the interactive brochure at https://bit.ly/2JYE5tI.This brochure was funded by an independent medical education grant from Pfizer Inc.

ginews@gastro.org

The AGA GI Patient Center has released a new brochure entitled “Biologic and biosimilar medicines: What you need to know.” The new brochure includes interactive elements like quizzes, medication sheets, symptom tracker, and the option of audibly listening to the pages.

The brochure provides patients with:

• An overview of the immune system.

• Background on immune-mediated conditions.

• Biologics and biosimilars: What are they?

• Information on biosimilars and generics.

• Cost of biologics and biosimilars.

• The importance of adhering to their treatment plan.

• Tips to start the conversation with their provider.

• Safety of biologics and biosimilars.

Share this new resource with your patients by printing, linking from your practice website, or emailing the link to your patients. Visit the AGA GI Patient Center page dedicated to biosimilars for more at gastro.org/biosimilars.

AGA members will also receive print copies of the new brochure this month. Order additional copies for your practice at http://www.agaresources.com/order_biosimilars.php. The brochure was reviewed by Jami Kinnucan, MD, and Rajeev Jain, MD, AGAF, AGA Patient Education Adviser.

View the interactive brochure at https://bit.ly/2JYE5tI.This brochure was funded by an independent medical education grant from Pfizer Inc.

ginews@gastro.org

The AGA GI Patient Center has released a new resource to support patients infected with C. difficile. The resource includes “Understanding C. diff infection” video and a patient brochure entitled “Navigating Your C. diff Diagnosis.”

C. diff, a bacterium known to cause bad GI symptoms like nausea and watery diarrhea, infects nearly 500,000 Americans every year and often calls for hospitalization. The AGA GI Patient Center has curated a new patient education page to assist and to share directly with your patients to prepare them for their visit. The article includes C. difficile-specific guidance on:

• Symptoms.

• Risk factors.

• Getting tested.

• Treatment.

• Complications.

Share this new resource with your patients by printing, linking from your practice website, or emailing the link to your patients. Visit gastro.org/cdiff to view the new video and brochure.

The “Navigating Your C. diff Diagnosis” brochure was reviewed by Rajeev Jain, MD, AGAF, AGA Patient Education Advisor, Texas Digestive Disease Consultants, Dallas, and Alexander Khoruts, MD, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board, University of Minnesota, Minneapolis. AGA members will also receive print copies of the new brochure this month.

This program was supported by an independent educational grant from Ferring Pharmaceuticals, Inc.

ginews@gastro.org

The AGA GI Patient Center has released a new resource to support patients infected with C. difficile. The resource includes “Understanding C. diff infection” video and a patient brochure entitled “Navigating Your C. diff Diagnosis.”

C. diff, a bacterium known to cause bad GI symptoms like nausea and watery diarrhea, infects nearly 500,000 Americans every year and often calls for hospitalization. The AGA GI Patient Center has curated a new patient education page to assist and to share directly with your patients to prepare them for their visit. The article includes C. difficile-specific guidance on:

• Symptoms.

• Risk factors.

• Getting tested.

• Treatment.

• Complications.

Share this new resource with your patients by printing, linking from your practice website, or emailing the link to your patients. Visit gastro.org/cdiff to view the new video and brochure.

The “Navigating Your C. diff Diagnosis” brochure was reviewed by Rajeev Jain, MD, AGAF, AGA Patient Education Advisor, Texas Digestive Disease Consultants, Dallas, and Alexander Khoruts, MD, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board, University of Minnesota, Minneapolis. AGA members will also receive print copies of the new brochure this month.

This program was supported by an independent educational grant from Ferring Pharmaceuticals, Inc.

ginews@gastro.org

The AGA GI Patient Center has released a new resource to support patients infected with C. difficile. The resource includes “Understanding C. diff infection” video and a patient brochure entitled “Navigating Your C. diff Diagnosis.”

C. diff, a bacterium known to cause bad GI symptoms like nausea and watery diarrhea, infects nearly 500,000 Americans every year and often calls for hospitalization. The AGA GI Patient Center has curated a new patient education page to assist and to share directly with your patients to prepare them for their visit. The article includes C. difficile-specific guidance on:

• Symptoms.

• Risk factors.

• Getting tested.

• Treatment.

• Complications.

Share this new resource with your patients by printing, linking from your practice website, or emailing the link to your patients. Visit gastro.org/cdiff to view the new video and brochure.

The “Navigating Your C. diff Diagnosis” brochure was reviewed by Rajeev Jain, MD, AGAF, AGA Patient Education Advisor, Texas Digestive Disease Consultants, Dallas, and Alexander Khoruts, MD, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board, University of Minnesota, Minneapolis. AGA members will also receive print copies of the new brochure this month.

This program was supported by an independent educational grant from Ferring Pharmaceuticals, Inc.

ginews@gastro.org

As the new year begins, we hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust.

It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

Including the AGA Research Foundation in your will is a popular gift to give because it is:

• Affordable. The actual giving of your gift occurs after your lifetime, so your current income is not affected.
• Flexible. Until your will goes into effect, you are free to alter your plans or change your mind.
• Versatile. You can give a specific item, a set amount of money, or a percentage of your estate. You can also make your gift contingent upon certain events.

Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website.

ginews@gastro.org

As the new year begins, we hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust.

It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

Including the AGA Research Foundation in your will is a popular gift to give because it is:

• Affordable. The actual giving of your gift occurs after your lifetime, so your current income is not affected.
• Flexible. Until your will goes into effect, you are free to alter your plans or change your mind.
• Versatile. You can give a specific item, a set amount of money, or a percentage of your estate. You can also make your gift contingent upon certain events.

Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website.

ginews@gastro.org

As the new year begins, we hope you’ll consider including a gift to the AGA Research Foundation in your will or living trust.

It’s simple – just a few sentences in your will or trust are all that is needed. The official bequest language for the AGA Research Foundation is: “I, [name], of [city, state, ZIP], give, devise and bequeath to the AGA Research Foundation [written amount or percentage of the estate or description of property] for its unrestricted use and purpose.”

Including the AGA Research Foundation in your will is a popular gift to give because it is:

• Affordable. The actual giving of your gift occurs after your lifetime, so your current income is not affected.
• Flexible. Until your will goes into effect, you are free to alter your plans or change your mind.
• Versatile. You can give a specific item, a set amount of money, or a percentage of your estate. You can also make your gift contingent upon certain events.

Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website.

ginews@gastro.org

Among children with moderate or severe persistent asthma, monitoring daily inhaler use with sensors and a mobile application may improve asthma symptom control and caregiver quality of life, a randomized trial suggests.

But the intervention also may lead to more ED visits and increased hospitalization rates.

“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.

The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
 

Adherence to preventive regimens

Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.

To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.

Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.

Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.

“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.

Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.

The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.

Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.

During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).

Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
 

Important area of research

“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”

The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.

“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.

The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.

Among children with moderate or severe persistent asthma, monitoring daily inhaler use with sensors and a mobile application may improve asthma symptom control and caregiver quality of life, a randomized trial suggests.

But the intervention also may lead to more ED visits and increased hospitalization rates.

“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.

The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
 

Adherence to preventive regimens

Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.

To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.

Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.

Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.

“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.

Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.

The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.

Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.

During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).

Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
 

Important area of research

“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”

The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.

“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.

The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.

Among children with moderate or severe persistent asthma, monitoring daily inhaler use with sensors and a mobile application may improve asthma symptom control and caregiver quality of life, a randomized trial suggests.

But the intervention also may lead to more ED visits and increased hospitalization rates.

“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.

The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
 

Adherence to preventive regimens

Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.

To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.

Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.

Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.

“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.

Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.

The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.

Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.

During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).

Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
 

Important area of research

“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”

The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.

“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.

The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.

The value of HPV vaccine for treating any cutaneous HPV-associated warts, not just genital lesions, has been suggested repeatedly in case reports and small studies, but a recently published review provides strong evidence that this is a practical clinical strategy, according to Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.

“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.

The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.

The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.

As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.

“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.

Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.

In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.

“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.

The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.

“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.

There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.

In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.

“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.

Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.

This publication and Global Academy for Medical Education are owned by the same parent company.

The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.

The value of HPV vaccine for treating any cutaneous HPV-associated warts, not just genital lesions, has been suggested repeatedly in case reports and small studies, but a recently published review provides strong evidence that this is a practical clinical strategy, according to Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.

“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.

The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.

The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.

As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.

“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.

Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.

In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.

“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.

The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.

“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.

There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.

In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.

“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.

Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.

This publication and Global Academy for Medical Education are owned by the same parent company.

The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.

The value of HPV vaccine for treating any cutaneous HPV-associated warts, not just genital lesions, has been suggested repeatedly in case reports and small studies, but a recently published review provides strong evidence that this is a practical clinical strategy, according to Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.

“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.

The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.

The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.

As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.

“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.

Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.

In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.

“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.

The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.

“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.

There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.

In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.

“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.

Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.

This publication and Global Academy for Medical Education are owned by the same parent company.

As 2020 comes to a close, most of us are looking forward to a (hopefully) brighter 2021. This year has been full of challenges and new experiences, but we have learned a lot. Pandemic or not, there are some things that you and your practice can do to ensure that you are prepared to make 2021 a success.

Tips for your practice

Assess staff morale: It seems simple but checking in with your staff can go a long way. Everyone is dealing with challenges both in and out of the workplace. Check in, show them you care, and think of ways that you can make their work a positive experience in the new year. During our May 2020 GI division chief townhall, John Inadomi, MD, gave a great presentation on the importance of staff morale during the pandemic.

Listen to colleagues: Find out about their experiences, challenges, and solutions. In October, the American Gastroenterological Association held a town hall with some great information and resources called “Adapting to Changing Practice Paradigms.” The agenda covered topics from telehealth to private equity and planning for the next potential wave of COVID-19.

Celebrate the wins: It can often feel like not much went right in 2020, but we did accomplish significant wins for GIs, including achieving payment parity for telephone evaluation and management (E/M) visits with video visits, increases in digestive disease and GI cancer research funding, and inclusion/expansion of GI cancers research opportunities. We couldn’t have done it without you, though, and we will continue to need your help to move important issues forward in 2021. Get involved today! Visit “Get Involved” under Advocacy and Policy on www.gastro.org.

Prepare for E/M changes: The Current Procedural Terminology (CPT) E/M for new and established patient office/outpatient codes (99201-99205, 99211-99215), guidelines, and Medicare payments will undergo major changes beginning Jan. 1, 2021. See the AGA’s coding and reimbursement experts’ article from the March 2020 issue of GI & Hepatology News, “Prepare for major changes to E/M coding starting in 2021,” to learn about the changes and get resources to help practices prepare.

Keep up with new Medicare payment rules: The release of the 2021 physician payments and rules for the Medicare program was delayed this year because of the COVID-19 public health emergency. We were dismayed to learn that Medicare did not make any changes that substantively mitigated the expected cuts to most specialties. Instead of a 5% cut for GI, the Centers for Medicare & Medicaid Services now projects GI will experience a 4% payment cut for 2021. AGA is calling on Congress to pass legislation to stop the cuts. This situation is evolving quickly. Watch for AGA member alerts for breaking news and resources, including the AGA’s “Medicare plans significant payment cuts for 2021.”

Stay current on telehealth and telephone E/M coverage: The commercial payer community came together to cover telehealth (video visits) and telephone E/M at the beginning of the COVID-19 pandemic but have since regularly teased the end of coverage only to extend it just before it expires. It’s impossible to predict what each payer will do, but you can use the following resources to keep current on most payers’ policies and correct coding/reporting for telehealth and telephone E/M:

• “Current State Laws & Reimbursement Policies ” from the Center for Connected Health.
• “Coding for Telehealth & Virtual Visits During COVID-19” from the AGA University.

Check to see if you can report on additional quality measures: AGA has expanded the Merit-Based Incentive Payment System (MIPS) measure portfolio by assuming ownership and stewardship of two hepatitis C virus (HCV) measures from PCPI, including annually checking for HCV in active injection drug users (measure 387) and performing a one-time screening for HCV among patients at risk (measure 400). As a result, gastroenterologists can now report on even more GI-specific measures. There have been the following two changes to GI-specific measures in 2021:

• Measure 275: “Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy” now includes coding to allow reporting for all age groups, including pediatric populations.
• Measure 439: “Age Appropriate Screening Colonoscopy” now includes all colonoscopies for patients 50 years and older; however, there’s an exclusion for those patients between the ages of 50 and 85 years.

These changes will help more gastroenterologists qualify for these measures.

Dates and deadlines to remember

January 2021

• Jan. 1 – MIPS Performance Year 2021 begins.
• Jan. 4 – Submission window opens for MIPS Performance Year 2020.
• Changes to Improvement Activity category go into effect (if approved in final rule).

March 2021

• March 31 – First snapshot for Qualifying Participant (QP) determinations and MIPS APM participation.

April 2021

• April 1 – Registration begins for CMS web interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey.

June 2021

• June 30 – Second snapshot for QP determinations and MIPS APM participation.
• June 30 – Registration ends for CMS web interface and CAHPS for MIPS survey.

July 2021

• CMS publishes proposed reimbursement values for 2022 in the Medicare Physician Fee Schedule proposed rule.
• CMS “Targeted Review” opens once CMS makes your MIPS payment adjustment available.
• July 1 - MIPS Performance Feedback Available. CMS will provide you with performance feedback based on the data you submitted for Performance Year 2020. You can use this feedback to improve your care and optimize the payments you receive from CMS in the future.

August 2021

• Aug. 31 - Targeted Review period closes (appeals process).

September 2021

• AMA releases CPT 2022 book, including a new CPT code for Peroral Endoscopic Myotomy (POEM).

October 2021

• Oct. 3 - Last day to start a 90-day performance period for promoting Interoperability and Improvement Activities.

November 2021

• CMS finalizes reimbursement values for 2022 in the MPFS final rule. New payment rates take effect Jan. 1, 2022.

December 2021

• Dec. 31 – Quality Payment Program Exception Applications window closes.
• Dec. 31 – MIPS Performance year 2020 ends.
• Dec. 31 – Fourth snapshot for full TIN APMs (Medicare Shared Savings Program).

G. Anton Decker, MD, is chair of the AGA Practice Management and Economics Committee, Mayo Clinic International; Dawn Francis, MD, is chair-elect of the AGA Practice Management and Economics Committee, Mayo Clinic, Jacksonville, Fla.

They have no conflicts of interest.

As 2020 comes to a close, most of us are looking forward to a (hopefully) brighter 2021. This year has been full of challenges and new experiences, but we have learned a lot. Pandemic or not, there are some things that you and your practice can do to ensure that you are prepared to make 2021 a success.

Tips for your practice

Assess staff morale: It seems simple but checking in with your staff can go a long way. Everyone is dealing with challenges both in and out of the workplace. Check in, show them you care, and think of ways that you can make their work a positive experience in the new year. During our May 2020 GI division chief townhall, John Inadomi, MD, gave a great presentation on the importance of staff morale during the pandemic.

Listen to colleagues: Find out about their experiences, challenges, and solutions. In October, the American Gastroenterological Association held a town hall with some great information and resources called “Adapting to Changing Practice Paradigms.” The agenda covered topics from telehealth to private equity and planning for the next potential wave of COVID-19.

Celebrate the wins: It can often feel like not much went right in 2020, but we did accomplish significant wins for GIs, including achieving payment parity for telephone evaluation and management (E/M) visits with video visits, increases in digestive disease and GI cancer research funding, and inclusion/expansion of GI cancers research opportunities. We couldn’t have done it without you, though, and we will continue to need your help to move important issues forward in 2021. Get involved today! Visit “Get Involved” under Advocacy and Policy on www.gastro.org.

Prepare for E/M changes: The Current Procedural Terminology (CPT) E/M for new and established patient office/outpatient codes (99201-99205, 99211-99215), guidelines, and Medicare payments will undergo major changes beginning Jan. 1, 2021. See the AGA’s coding and reimbursement experts’ article from the March 2020 issue of GI & Hepatology News, “Prepare for major changes to E/M coding starting in 2021,” to learn about the changes and get resources to help practices prepare.

Keep up with new Medicare payment rules: The release of the 2021 physician payments and rules for the Medicare program was delayed this year because of the COVID-19 public health emergency. We were dismayed to learn that Medicare did not make any changes that substantively mitigated the expected cuts to most specialties. Instead of a 5% cut for GI, the Centers for Medicare & Medicaid Services now projects GI will experience a 4% payment cut for 2021. AGA is calling on Congress to pass legislation to stop the cuts. This situation is evolving quickly. Watch for AGA member alerts for breaking news and resources, including the AGA’s “Medicare plans significant payment cuts for 2021.”

Stay current on telehealth and telephone E/M coverage: The commercial payer community came together to cover telehealth (video visits) and telephone E/M at the beginning of the COVID-19 pandemic but have since regularly teased the end of coverage only to extend it just before it expires. It’s impossible to predict what each payer will do, but you can use the following resources to keep current on most payers’ policies and correct coding/reporting for telehealth and telephone E/M:

• “Current State Laws & Reimbursement Policies ” from the Center for Connected Health.
• “Coding for Telehealth & Virtual Visits During COVID-19” from the AGA University.

Check to see if you can report on additional quality measures: AGA has expanded the Merit-Based Incentive Payment System (MIPS) measure portfolio by assuming ownership and stewardship of two hepatitis C virus (HCV) measures from PCPI, including annually checking for HCV in active injection drug users (measure 387) and performing a one-time screening for HCV among patients at risk (measure 400). As a result, gastroenterologists can now report on even more GI-specific measures. There have been the following two changes to GI-specific measures in 2021:

• Measure 275: “Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy” now includes coding to allow reporting for all age groups, including pediatric populations.
• Measure 439: “Age Appropriate Screening Colonoscopy” now includes all colonoscopies for patients 50 years and older; however, there’s an exclusion for those patients between the ages of 50 and 85 years.

These changes will help more gastroenterologists qualify for these measures.

Dates and deadlines to remember

January 2021

• Jan. 1 – MIPS Performance Year 2021 begins.
• Jan. 4 – Submission window opens for MIPS Performance Year 2020.
• Changes to Improvement Activity category go into effect (if approved in final rule).

March 2021

• March 31 – First snapshot for Qualifying Participant (QP) determinations and MIPS APM participation.

April 2021

• April 1 – Registration begins for CMS web interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey.

June 2021

• June 30 – Second snapshot for QP determinations and MIPS APM participation.
• June 30 – Registration ends for CMS web interface and CAHPS for MIPS survey.

July 2021

• CMS publishes proposed reimbursement values for 2022 in the Medicare Physician Fee Schedule proposed rule.
• CMS “Targeted Review” opens once CMS makes your MIPS payment adjustment available.
• July 1 - MIPS Performance Feedback Available. CMS will provide you with performance feedback based on the data you submitted for Performance Year 2020. You can use this feedback to improve your care and optimize the payments you receive from CMS in the future.

August 2021

• Aug. 31 - Targeted Review period closes (appeals process).

September 2021

• AMA releases CPT 2022 book, including a new CPT code for Peroral Endoscopic Myotomy (POEM).

October 2021

• Oct. 3 - Last day to start a 90-day performance period for promoting Interoperability and Improvement Activities.

November 2021

• CMS finalizes reimbursement values for 2022 in the MPFS final rule. New payment rates take effect Jan. 1, 2022.

December 2021

• Dec. 31 – Quality Payment Program Exception Applications window closes.
• Dec. 31 – MIPS Performance year 2020 ends.
• Dec. 31 – Fourth snapshot for full TIN APMs (Medicare Shared Savings Program).

G. Anton Decker, MD, is chair of the AGA Practice Management and Economics Committee, Mayo Clinic International; Dawn Francis, MD, is chair-elect of the AGA Practice Management and Economics Committee, Mayo Clinic, Jacksonville, Fla.

They have no conflicts of interest.

As 2020 comes to a close, most of us are looking forward to a (hopefully) brighter 2021. This year has been full of challenges and new experiences, but we have learned a lot. Pandemic or not, there are some things that you and your practice can do to ensure that you are prepared to make 2021 a success.

Tips for your practice

Assess staff morale: It seems simple but checking in with your staff can go a long way. Everyone is dealing with challenges both in and out of the workplace. Check in, show them you care, and think of ways that you can make their work a positive experience in the new year. During our May 2020 GI division chief townhall, John Inadomi, MD, gave a great presentation on the importance of staff morale during the pandemic.

Listen to colleagues: Find out about their experiences, challenges, and solutions. In October, the American Gastroenterological Association held a town hall with some great information and resources called “Adapting to Changing Practice Paradigms.” The agenda covered topics from telehealth to private equity and planning for the next potential wave of COVID-19.

Celebrate the wins: It can often feel like not much went right in 2020, but we did accomplish significant wins for GIs, including achieving payment parity for telephone evaluation and management (E/M) visits with video visits, increases in digestive disease and GI cancer research funding, and inclusion/expansion of GI cancers research opportunities. We couldn’t have done it without you, though, and we will continue to need your help to move important issues forward in 2021. Get involved today! Visit “Get Involved” under Advocacy and Policy on www.gastro.org.

Prepare for E/M changes: The Current Procedural Terminology (CPT) E/M for new and established patient office/outpatient codes (99201-99205, 99211-99215), guidelines, and Medicare payments will undergo major changes beginning Jan. 1, 2021. See the AGA’s coding and reimbursement experts’ article from the March 2020 issue of GI & Hepatology News, “Prepare for major changes to E/M coding starting in 2021,” to learn about the changes and get resources to help practices prepare.

Keep up with new Medicare payment rules: The release of the 2021 physician payments and rules for the Medicare program was delayed this year because of the COVID-19 public health emergency. We were dismayed to learn that Medicare did not make any changes that substantively mitigated the expected cuts to most specialties. Instead of a 5% cut for GI, the Centers for Medicare & Medicaid Services now projects GI will experience a 4% payment cut for 2021. AGA is calling on Congress to pass legislation to stop the cuts. This situation is evolving quickly. Watch for AGA member alerts for breaking news and resources, including the AGA’s “Medicare plans significant payment cuts for 2021.”

Stay current on telehealth and telephone E/M coverage: The commercial payer community came together to cover telehealth (video visits) and telephone E/M at the beginning of the COVID-19 pandemic but have since regularly teased the end of coverage only to extend it just before it expires. It’s impossible to predict what each payer will do, but you can use the following resources to keep current on most payers’ policies and correct coding/reporting for telehealth and telephone E/M:

• “Current State Laws & Reimbursement Policies ” from the Center for Connected Health.
• “Coding for Telehealth & Virtual Visits During COVID-19” from the AGA University.

Check to see if you can report on additional quality measures: AGA has expanded the Merit-Based Incentive Payment System (MIPS) measure portfolio by assuming ownership and stewardship of two hepatitis C virus (HCV) measures from PCPI, including annually checking for HCV in active injection drug users (measure 387) and performing a one-time screening for HCV among patients at risk (measure 400). As a result, gastroenterologists can now report on even more GI-specific measures. There have been the following two changes to GI-specific measures in 2021:

• Measure 275: “Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy” now includes coding to allow reporting for all age groups, including pediatric populations.
• Measure 439: “Age Appropriate Screening Colonoscopy” now includes all colonoscopies for patients 50 years and older; however, there’s an exclusion for those patients between the ages of 50 and 85 years.

These changes will help more gastroenterologists qualify for these measures.

Dates and deadlines to remember

January 2021

• Jan. 1 – MIPS Performance Year 2021 begins.
• Jan. 4 – Submission window opens for MIPS Performance Year 2020.
• Changes to Improvement Activity category go into effect (if approved in final rule).

March 2021

• March 31 – First snapshot for Qualifying Participant (QP) determinations and MIPS APM participation.

April 2021

• April 1 – Registration begins for CMS web interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey.

June 2021

• June 30 – Second snapshot for QP determinations and MIPS APM participation.
• June 30 – Registration ends for CMS web interface and CAHPS for MIPS survey.

July 2021

• CMS publishes proposed reimbursement values for 2022 in the Medicare Physician Fee Schedule proposed rule.
• CMS “Targeted Review” opens once CMS makes your MIPS payment adjustment available.
• July 1 - MIPS Performance Feedback Available. CMS will provide you with performance feedback based on the data you submitted for Performance Year 2020. You can use this feedback to improve your care and optimize the payments you receive from CMS in the future.

August 2021

• Aug. 31 - Targeted Review period closes (appeals process).

September 2021

• AMA releases CPT 2022 book, including a new CPT code for Peroral Endoscopic Myotomy (POEM).

October 2021

• Oct. 3 - Last day to start a 90-day performance period for promoting Interoperability and Improvement Activities.

November 2021

• CMS finalizes reimbursement values for 2022 in the MPFS final rule. New payment rates take effect Jan. 1, 2022.

December 2021

• Dec. 31 – Quality Payment Program Exception Applications window closes.
• Dec. 31 – MIPS Performance year 2020 ends.
• Dec. 31 – Fourth snapshot for full TIN APMs (Medicare Shared Savings Program).

G. Anton Decker, MD, is chair of the AGA Practice Management and Economics Committee, Mayo Clinic International; Dawn Francis, MD, is chair-elect of the AGA Practice Management and Economics Committee, Mayo Clinic, Jacksonville, Fla.

They have no conflicts of interest.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Despite the lack of any Food and Drug Administration–approved medications for vitiligo, there are plenty of treatment options, and therapy can make a big difference in an individual’s quality of life, according to Seemal Desai, MD, of the University of Texas, Dallas.

“We have topical steroids. We have vitamin D analogs, calcineurin inhibitors, and depigmentation therapy. We also have systemic therapy, phototherapy, surgical treatment, and even psychological therapy, Dr. Desai said in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Head and neck vitiligo, which “tends to respond very nicely to treatment,” is one of the affected areas “where we have an important obligation to make sure our patients are effectively and aggressively treated,” he said.

According to Dr. Desai, there are three kinds of vitiligo. Active/unstable vitiligo is marked by depigmentation spreading across 1%-2% of body surface area per month, the size of about one to two palms. Refractory vitiligo responds poorly to therapy with less than 25% of affected areas experiencing repigmentation. And the third type is chronic vitiligo. “The majority of patients we see are in this phase, where depigmentation is present for at least 1 year with no history of spontaneous repigmentation.”

Before turning to therapy, he said, make sure to understand what the patient wants. “Are they even interested in being treated? I’ve had some patients with vitiligo, it’s only on their chest, and they’re always covered. They don’t even want anything. Then I have other patients who only want their face and hands treated because those are the only parts of their body that are exposed.”

To stabilize vitiligo, Dr. Desai recommends treating patients with “mini-pulse” oral therapy with systemic steroids. “I prescribe 4 milligrams of dexamethasone to be taken 2 consecutive days per week, such as Saturdays and Sundays. I usually halve the dose in children aged less than 16 years of age, so they’d be taking 2 milligrams.” Make sure, he said, to counsel patients on side effects.

He also recommends antioxidants, particularly polypodium leucotomos, “which has been shown in studies to increase the rates of head and neck repigmentation when combined with narrowband UVB.” He recommends 240 milligrams or higher, 2 or 3 times a day. He adds that alpha lipoic acid – in combination with vitamin C, vitamin E, and phototherapy – has also been shown to be effective in inducing repigmentation, especially on the head and neck.

As for newer drugs, Dr. Desai said afamelanotide, an analogue of alpha melanocyte-stimulating hormone combined with phototherapy, has shown promise. (It was approved in 2019 to increase pain free light exposure in adults with a history of phototoxic reactions related to erythropoietic protoporphyria.) Like other medications he mentioned, it isn’t FDA approved for treating vitiligo.

On another front, “Janus kinase inhibitors are our new frontier in treating vitiligo,” he said. “Tofacitinib can be dosed as an off-label usage in vitiligo in doses of 5 milligrams every other day, up to 5 milligrams daily. It’s half of the dose of rheumatoid arthritis, which is 5 milligrams b.i.d. You can actually start to see repigmentation as soon as 2 months, and then improvement up to 5 months.”

The drug requires laboratory monitoring and is expensive, he said, and JAK inhibitor side effects must be discussed with all patients.

Topical JAK inhibitors – tofacitinib 2% cream and ruxolitinib 1.5% cream – are also being evaluated as treatment for vitiligo. “I find that ruxolitinib works a little bit better, and the early bit of vitiligo data has shown that it tends to have more of a robust pigmentation response compared to tofacitinib,” said Dr. Desai, who gets these drugs compounded for topical use.

Dr. Desai added that he prefers to combine JAK inhibitors with phototherapy when possible.

For resistant vitiligo, he said, “lasers can help, especially Q-switched ruby and Q-switched Alexandrite laser. Q-switched Nd:Yag is very popular in Asia.”

In the big picture, he said, patients can benefit greatly from treatment. “Just think about the psychological improvement a patient would get by not having to get stares when walking in a mall and not having to deal with vitiligo lesions all over their cheek and neck.”

Dr. Desai disclosed performing clinical trials and/or consulting for numerous companies, including Pfizer, Allergan, AbbVie, and Dr. Reddy’s, among others. MedscapeLive and this news organization are owned by the same parent company.

Despite the lack of any Food and Drug Administration–approved medications for vitiligo, there are plenty of treatment options, and therapy can make a big difference in an individual’s quality of life, according to Seemal Desai, MD, of the University of Texas, Dallas.

“We have topical steroids. We have vitamin D analogs, calcineurin inhibitors, and depigmentation therapy. We also have systemic therapy, phototherapy, surgical treatment, and even psychological therapy, Dr. Desai said in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Head and neck vitiligo, which “tends to respond very nicely to treatment,” is one of the affected areas “where we have an important obligation to make sure our patients are effectively and aggressively treated,” he said.

According to Dr. Desai, there are three kinds of vitiligo. Active/unstable vitiligo is marked by depigmentation spreading across 1%-2% of body surface area per month, the size of about one to two palms. Refractory vitiligo responds poorly to therapy with less than 25% of affected areas experiencing repigmentation. And the third type is chronic vitiligo. “The majority of patients we see are in this phase, where depigmentation is present for at least 1 year with no history of spontaneous repigmentation.”

Before turning to therapy, he said, make sure to understand what the patient wants. “Are they even interested in being treated? I’ve had some patients with vitiligo, it’s only on their chest, and they’re always covered. They don’t even want anything. Then I have other patients who only want their face and hands treated because those are the only parts of their body that are exposed.”

To stabilize vitiligo, Dr. Desai recommends treating patients with “mini-pulse” oral therapy with systemic steroids. “I prescribe 4 milligrams of dexamethasone to be taken 2 consecutive days per week, such as Saturdays and Sundays. I usually halve the dose in children aged less than 16 years of age, so they’d be taking 2 milligrams.” Make sure, he said, to counsel patients on side effects.

He also recommends antioxidants, particularly polypodium leucotomos, “which has been shown in studies to increase the rates of head and neck repigmentation when combined with narrowband UVB.” He recommends 240 milligrams or higher, 2 or 3 times a day. He adds that alpha lipoic acid – in combination with vitamin C, vitamin E, and phototherapy – has also been shown to be effective in inducing repigmentation, especially on the head and neck.

As for newer drugs, Dr. Desai said afamelanotide, an analogue of alpha melanocyte-stimulating hormone combined with phototherapy, has shown promise. (It was approved in 2019 to increase pain free light exposure in adults with a history of phototoxic reactions related to erythropoietic protoporphyria.) Like other medications he mentioned, it isn’t FDA approved for treating vitiligo.

On another front, “Janus kinase inhibitors are our new frontier in treating vitiligo,” he said. “Tofacitinib can be dosed as an off-label usage in vitiligo in doses of 5 milligrams every other day, up to 5 milligrams daily. It’s half of the dose of rheumatoid arthritis, which is 5 milligrams b.i.d. You can actually start to see repigmentation as soon as 2 months, and then improvement up to 5 months.”

The drug requires laboratory monitoring and is expensive, he said, and JAK inhibitor side effects must be discussed with all patients.

Topical JAK inhibitors – tofacitinib 2% cream and ruxolitinib 1.5% cream – are also being evaluated as treatment for vitiligo. “I find that ruxolitinib works a little bit better, and the early bit of vitiligo data has shown that it tends to have more of a robust pigmentation response compared to tofacitinib,” said Dr. Desai, who gets these drugs compounded for topical use.

Dr. Desai added that he prefers to combine JAK inhibitors with phototherapy when possible.

For resistant vitiligo, he said, “lasers can help, especially Q-switched ruby and Q-switched Alexandrite laser. Q-switched Nd:Yag is very popular in Asia.”

In the big picture, he said, patients can benefit greatly from treatment. “Just think about the psychological improvement a patient would get by not having to get stares when walking in a mall and not having to deal with vitiligo lesions all over their cheek and neck.”

Dr. Desai disclosed performing clinical trials and/or consulting for numerous companies, including Pfizer, Allergan, AbbVie, and Dr. Reddy’s, among others. MedscapeLive and this news organization are owned by the same parent company.

Despite the lack of any Food and Drug Administration–approved medications for vitiligo, there are plenty of treatment options, and therapy can make a big difference in an individual’s quality of life, according to Seemal Desai, MD, of the University of Texas, Dallas.

“We have topical steroids. We have vitamin D analogs, calcineurin inhibitors, and depigmentation therapy. We also have systemic therapy, phototherapy, surgical treatment, and even psychological therapy, Dr. Desai said in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Head and neck vitiligo, which “tends to respond very nicely to treatment,” is one of the affected areas “where we have an important obligation to make sure our patients are effectively and aggressively treated,” he said.

According to Dr. Desai, there are three kinds of vitiligo. Active/unstable vitiligo is marked by depigmentation spreading across 1%-2% of body surface area per month, the size of about one to two palms. Refractory vitiligo responds poorly to therapy with less than 25% of affected areas experiencing repigmentation. And the third type is chronic vitiligo. “The majority of patients we see are in this phase, where depigmentation is present for at least 1 year with no history of spontaneous repigmentation.”

Before turning to therapy, he said, make sure to understand what the patient wants. “Are they even interested in being treated? I’ve had some patients with vitiligo, it’s only on their chest, and they’re always covered. They don’t even want anything. Then I have other patients who only want their face and hands treated because those are the only parts of their body that are exposed.”

To stabilize vitiligo, Dr. Desai recommends treating patients with “mini-pulse” oral therapy with systemic steroids. “I prescribe 4 milligrams of dexamethasone to be taken 2 consecutive days per week, such as Saturdays and Sundays. I usually halve the dose in children aged less than 16 years of age, so they’d be taking 2 milligrams.” Make sure, he said, to counsel patients on side effects.

He also recommends antioxidants, particularly polypodium leucotomos, “which has been shown in studies to increase the rates of head and neck repigmentation when combined with narrowband UVB.” He recommends 240 milligrams or higher, 2 or 3 times a day. He adds that alpha lipoic acid – in combination with vitamin C, vitamin E, and phototherapy – has also been shown to be effective in inducing repigmentation, especially on the head and neck.

As for newer drugs, Dr. Desai said afamelanotide, an analogue of alpha melanocyte-stimulating hormone combined with phototherapy, has shown promise. (It was approved in 2019 to increase pain free light exposure in adults with a history of phototoxic reactions related to erythropoietic protoporphyria.) Like other medications he mentioned, it isn’t FDA approved for treating vitiligo.

On another front, “Janus kinase inhibitors are our new frontier in treating vitiligo,” he said. “Tofacitinib can be dosed as an off-label usage in vitiligo in doses of 5 milligrams every other day, up to 5 milligrams daily. It’s half of the dose of rheumatoid arthritis, which is 5 milligrams b.i.d. You can actually start to see repigmentation as soon as 2 months, and then improvement up to 5 months.”

The drug requires laboratory monitoring and is expensive, he said, and JAK inhibitor side effects must be discussed with all patients.

Topical JAK inhibitors – tofacitinib 2% cream and ruxolitinib 1.5% cream – are also being evaluated as treatment for vitiligo. “I find that ruxolitinib works a little bit better, and the early bit of vitiligo data has shown that it tends to have more of a robust pigmentation response compared to tofacitinib,” said Dr. Desai, who gets these drugs compounded for topical use.

Dr. Desai added that he prefers to combine JAK inhibitors with phototherapy when possible.

For resistant vitiligo, he said, “lasers can help, especially Q-switched ruby and Q-switched Alexandrite laser. Q-switched Nd:Yag is very popular in Asia.”

In the big picture, he said, patients can benefit greatly from treatment. “Just think about the psychological improvement a patient would get by not having to get stares when walking in a mall and not having to deal with vitiligo lesions all over their cheek and neck.”

Dr. Desai disclosed performing clinical trials and/or consulting for numerous companies, including Pfizer, Allergan, AbbVie, and Dr. Reddy’s, among others. MedscapeLive and this news organization are owned by the same parent company.