Practice Management

In a webinar conducted on March 20, Leonard Valentino, MD, president and CEO of the National Hemophilia Foundation (NHF), provided specific information of relevance and some reassurance to the bleeding disorders community on the impact of COVID-19.

Overall, the risk of comorbidities is no different in the bleeding disorders population than in the general population, and similar precautions should be maintained, Dr. Valentino stated. He listed some of the at-risk populations as designated by the Centers for Disease Control and Prevention.

In particular, he pointed out that, when the CDC referred to a greater risk of COVID-19 to individuals with bleeding disorders, the organization was referring to patients with HIV and sickle cell disease. The CDC was not referring to patients with other forms of bleeding disorders, such as hemophilia, Dr. Valentino stated.

All individuals should be following CDC and state and federal recommendations with regard to social distancing and hygiene. However, with regard to immunocompromised individuals, “the two populations we [in the bleeding disorders community] have to be concerned about are those in gene therapy clinical trials and those with inhibitors,” said Dr. Valentino.

Patients in a gene therapy clinical trial should exercise additional precautions because the use of steroids, common in these trials. “Steroids are an immunosuppressive drug, and this would increase one’s risk of infection, including COVID-19,” according to Dr. Valentino.

In addition, “I will say, if you have hemophilia and an inhibitor [an antibody to clotting factor treatment], that may alter the immune system, and we don’t know what the implication of that is in terms of coronavirus infection and COVID-19 disease. So people with an inhibitor should take special precautions to limit their exposures.”

Patients with a port should not need to have extra concerns regarding COVID-19, but they should continue to exercise the good hygiene that has always been essential, according to Dr. Valentino.

Dr. Valentino asked: Are patients with a bleeding disorder who become infected with COVID-19 more susceptible to a bleed? “You shouldn’t be more susceptible to bleeding except if you have severe cough, and that cough could result in bleeding to the head,” he answered.

If a patient needs to go to the emergency department for a bleed or possible COVID-19 infection, they should wear a face mask if they are sick to prevent spreading of disease. “This is really the only instance where a face mask may be beneficial” in that it limits other people’s exposure to your infection. It is especially important to call ahead before visiting the doctor or going to the emergency department. “Make sure that they’re aware that you’re coming.”

Of particular concern to patients is the amount of factor product they should have on hand. The current CDC recommendation is a 30-day supply of medicines, but that is misleading, because it refers to general medications, such as high-blood pressure medicine, and not factor products. “The current MASAC [NHF’s Medical and Scientific Advisory Council] recommendation is to have a 14-day supply of factor products available to you,” said Dr. Valentino, “and one should reorder when you have a 1-week supply.”

MASAC has issued a letter on the crisis on the NHF website.

These recommendations should not be exceeded in order to ensure that there is enough factor available to all patients, he added. Hoarding is discouraged, and there are no concerns as yet of factor running out. “We have had conversations with manufacturers and … the supply chain is robust.” The greater concern is with regard to ancillary supplies in the hospital that a hemophilia patient may require during treatment.

Patients and practitioners should consult the COVID-19 pages of both the NHF and Hemophilia Federation of America (HFA) websites. This includes a Health and Wellness update by Dr. Valentino.

With regard to financial issues, he and Sharon Meyers, CEO and president of the HFA, spoke, stating that both NHF and HFA have advocacy for patients seeking to deal with insurance issues or in paying for their products, urging people to go to the organizational websites and to also use their emails: [email protected] and [email protected].

She also announced that the annual meeting of the HFA was being postponed to Aug. 24-26 at the Hilton Inner Harbor Baltimore, Md.

Dr. Valentino and Ms. Meyers did not provide any disclosure information.

[email protected]

In a webinar conducted on March 20, Leonard Valentino, MD, president and CEO of the National Hemophilia Foundation (NHF), provided specific information of relevance and some reassurance to the bleeding disorders community on the impact of COVID-19.

Overall, the risk of comorbidities is no different in the bleeding disorders population than in the general population, and similar precautions should be maintained, Dr. Valentino stated. He listed some of the at-risk populations as designated by the Centers for Disease Control and Prevention.

In particular, he pointed out that, when the CDC referred to a greater risk of COVID-19 to individuals with bleeding disorders, the organization was referring to patients with HIV and sickle cell disease. The CDC was not referring to patients with other forms of bleeding disorders, such as hemophilia, Dr. Valentino stated.

All individuals should be following CDC and state and federal recommendations with regard to social distancing and hygiene. However, with regard to immunocompromised individuals, “the two populations we [in the bleeding disorders community] have to be concerned about are those in gene therapy clinical trials and those with inhibitors,” said Dr. Valentino.

Patients in a gene therapy clinical trial should exercise additional precautions because the use of steroids, common in these trials. “Steroids are an immunosuppressive drug, and this would increase one’s risk of infection, including COVID-19,” according to Dr. Valentino.

In addition, “I will say, if you have hemophilia and an inhibitor [an antibody to clotting factor treatment], that may alter the immune system, and we don’t know what the implication of that is in terms of coronavirus infection and COVID-19 disease. So people with an inhibitor should take special precautions to limit their exposures.”

Patients with a port should not need to have extra concerns regarding COVID-19, but they should continue to exercise the good hygiene that has always been essential, according to Dr. Valentino.

Dr. Valentino asked: Are patients with a bleeding disorder who become infected with COVID-19 more susceptible to a bleed? “You shouldn’t be more susceptible to bleeding except if you have severe cough, and that cough could result in bleeding to the head,” he answered.

If a patient needs to go to the emergency department for a bleed or possible COVID-19 infection, they should wear a face mask if they are sick to prevent spreading of disease. “This is really the only instance where a face mask may be beneficial” in that it limits other people’s exposure to your infection. It is especially important to call ahead before visiting the doctor or going to the emergency department. “Make sure that they’re aware that you’re coming.”

Of particular concern to patients is the amount of factor product they should have on hand. The current CDC recommendation is a 30-day supply of medicines, but that is misleading, because it refers to general medications, such as high-blood pressure medicine, and not factor products. “The current MASAC [NHF’s Medical and Scientific Advisory Council] recommendation is to have a 14-day supply of factor products available to you,” said Dr. Valentino, “and one should reorder when you have a 1-week supply.”

MASAC has issued a letter on the crisis on the NHF website.

These recommendations should not be exceeded in order to ensure that there is enough factor available to all patients, he added. Hoarding is discouraged, and there are no concerns as yet of factor running out. “We have had conversations with manufacturers and … the supply chain is robust.” The greater concern is with regard to ancillary supplies in the hospital that a hemophilia patient may require during treatment.

Patients and practitioners should consult the COVID-19 pages of both the NHF and Hemophilia Federation of America (HFA) websites. This includes a Health and Wellness update by Dr. Valentino.

With regard to financial issues, he and Sharon Meyers, CEO and president of the HFA, spoke, stating that both NHF and HFA have advocacy for patients seeking to deal with insurance issues or in paying for their products, urging people to go to the organizational websites and to also use their emails: [email protected] and [email protected].

She also announced that the annual meeting of the HFA was being postponed to Aug. 24-26 at the Hilton Inner Harbor Baltimore, Md.

Dr. Valentino and Ms. Meyers did not provide any disclosure information.

[email protected]

In a webinar conducted on March 20, Leonard Valentino, MD, president and CEO of the National Hemophilia Foundation (NHF), provided specific information of relevance and some reassurance to the bleeding disorders community on the impact of COVID-19.

Overall, the risk of comorbidities is no different in the bleeding disorders population than in the general population, and similar precautions should be maintained, Dr. Valentino stated. He listed some of the at-risk populations as designated by the Centers for Disease Control and Prevention.

In particular, he pointed out that, when the CDC referred to a greater risk of COVID-19 to individuals with bleeding disorders, the organization was referring to patients with HIV and sickle cell disease. The CDC was not referring to patients with other forms of bleeding disorders, such as hemophilia, Dr. Valentino stated.

All individuals should be following CDC and state and federal recommendations with regard to social distancing and hygiene. However, with regard to immunocompromised individuals, “the two populations we [in the bleeding disorders community] have to be concerned about are those in gene therapy clinical trials and those with inhibitors,” said Dr. Valentino.

Patients in a gene therapy clinical trial should exercise additional precautions because the use of steroids, common in these trials. “Steroids are an immunosuppressive drug, and this would increase one’s risk of infection, including COVID-19,” according to Dr. Valentino.

In addition, “I will say, if you have hemophilia and an inhibitor [an antibody to clotting factor treatment], that may alter the immune system, and we don’t know what the implication of that is in terms of coronavirus infection and COVID-19 disease. So people with an inhibitor should take special precautions to limit their exposures.”

Patients with a port should not need to have extra concerns regarding COVID-19, but they should continue to exercise the good hygiene that has always been essential, according to Dr. Valentino.

Dr. Valentino asked: Are patients with a bleeding disorder who become infected with COVID-19 more susceptible to a bleed? “You shouldn’t be more susceptible to bleeding except if you have severe cough, and that cough could result in bleeding to the head,” he answered.

If a patient needs to go to the emergency department for a bleed or possible COVID-19 infection, they should wear a face mask if they are sick to prevent spreading of disease. “This is really the only instance where a face mask may be beneficial” in that it limits other people’s exposure to your infection. It is especially important to call ahead before visiting the doctor or going to the emergency department. “Make sure that they’re aware that you’re coming.”

Of particular concern to patients is the amount of factor product they should have on hand. The current CDC recommendation is a 30-day supply of medicines, but that is misleading, because it refers to general medications, such as high-blood pressure medicine, and not factor products. “The current MASAC [NHF’s Medical and Scientific Advisory Council] recommendation is to have a 14-day supply of factor products available to you,” said Dr. Valentino, “and one should reorder when you have a 1-week supply.”

MASAC has issued a letter on the crisis on the NHF website.

These recommendations should not be exceeded in order to ensure that there is enough factor available to all patients, he added. Hoarding is discouraged, and there are no concerns as yet of factor running out. “We have had conversations with manufacturers and … the supply chain is robust.” The greater concern is with regard to ancillary supplies in the hospital that a hemophilia patient may require during treatment.

Patients and practitioners should consult the COVID-19 pages of both the NHF and Hemophilia Federation of America (HFA) websites. This includes a Health and Wellness update by Dr. Valentino.

With regard to financial issues, he and Sharon Meyers, CEO and president of the HFA, spoke, stating that both NHF and HFA have advocacy for patients seeking to deal with insurance issues or in paying for their products, urging people to go to the organizational websites and to also use their emails: [email protected] and [email protected].

She also announced that the annual meeting of the HFA was being postponed to Aug. 24-26 at the Hilton Inner Harbor Baltimore, Md.

Dr. Valentino and Ms. Meyers did not provide any disclosure information.

[email protected]

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

[email protected]

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

[email protected]

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

[email protected]

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

As gastroenterologists and gastrointestinal researchers, we work with an increasingly diverse patient population amid known disparities in health care delivery and health outcomes. The American Gastroenterological Association values diversity and inclusion, and part of its strategic plan is to increase and diversify its membership and leaders. The AGA Diversity Committee supports this strategic goal by fostering and promoting involvement, advancement, and recognition of underrepresented diverse constituencies. This is accomplished through policy recommendations and programs, providing resources to AGA members for addressing barriers to access and utilization of health care services among diverse patient populations with attention to linguistic, racial, cultural, religious, sexual orientation, gender identity, disability, age, and economic diversity.

There are eight clinician and investigator members, including the chair as well as one trainee member on the AGA Diversity Committee. Four members are appointed at-large and three members are appointed from the AGA Institute Committees and the AGA Institute Council. The committee has set out to achieve mission-driven goals with several initiatives that align with its intention to cultivate a diverse, inclusive, and engaged membership, armed with the necessary tools to provide the highest quality care and perform the most effective research that will benefit our patient population.

The communications task force highlights programs and topics that support the committee’s missions. Members of the committee coauthored a paper on colorectal disparities published in GI & Hepatology News in May 2018.¹ In addition to presenting the disparities in colorectal screening, it provided ways to close this gap. A more recent publication in AGA Perspectives focused on unconscious bias as a prelude to the committee’s workshop at Digestive Disease Week^® (DDW) 2019.² An important initiative has been promoting Black History Month in February and Pride Month in June by posting cases or displaying prominent trailblazers on the AGA Community. In the upcoming months, profiles of several committee members will be featured in eDigest, GI & Hepatology News, and on AGA’s social media platforms.

DDW programming sponsored by the Diversity Committee is an important way to engage our members. At DDW 2019, the committee sponsored a clinical symposium title “Beyond Starbucks: Mitigating Bias Through Awareness.” This session was inspired by the 2018 incidence hallmarked by the inappropriate arrest of two African American men at a Philadelphia Starbucks. This event led to a nationwide educational breakout for all employees aimed at providing unconscious bias training. The Diversity Committee drew inspiration from these events, holding a symposium with set goals of defining unconscious bias and identifying areas within health care where unconscious bias can influence patient care. The committee invited Allyson Dylan Robinson, a portfolio lead from the Association of American Medical Colleges–endorsed Cook Ross Firm, who is nationally recognized as a leader in unconscious bias training. The assembly began with an introductory lecture followed by breakout sessions where small groups reviewed selected patient cases to determine the influence of unconscious bias in clinical scenarios. It was a well-attended symposium and was complementary to the wide array of didactic lectures offered at DDW. Bringing to light significant issues and barriers to health care is one key aspect of the mission set forth by the Diversity Committee.

The AGA Diversity Committee e-poster tour at DDW 2019 promoted the research led by scientist and physician members of underrepresented groups in medicine and/or research focused on gastrointestinal diseases in underrepresented populations. Several high-quality abstracts were reviewed and four were selected for the e-poster tour. Each scientist presented their research in front of an enthusiastic audience of DDW attendees, followed by a question and answer session. Gonzalo Parodi, BS (Cedars-Sinai Medical Center, Los Angeles), presented an elegant study showing that the antibiotic changes to intestinal microbiome were sex specific in mice. Alexis Rivera, MD (University of Puerto Rico, San Juan), found no association between inflammatory bowel disease (IBD) serologic markers and risk of surgery in patients with IBD in Puerto Rico. Maria Gonzalez-Pons, PhD (University of Puerto Rico Comprehensive Cancer Center, San Juan), presented the first study looking at the mutational landscape of early-onset colorectal cancer tumors in Puerto Rican Hispanics, as a first step toward personalizing early screening in this population. Finally, Sushrut Jangi, MD (Brigham and Women’s Hospital, Boston), presented the first longitudinal study describing the unique demographic and phenotypic characteristics of IBD in South Asians living in the United States, showing that smoking was less relevant as a risk factor, and that Crohn’s presented with a more aggressive penetrating phenotype in this population. At the conclusion of the e-poster tour, attendees and presenters had the opportunity to exchange future research ideas or follow-up and network.

The upcoming DDW 2020 AGA Diversity Committee–sponsored symposium entitled “GI Health Disparities and Creating Affirming Environments for the LGBT+ Community: The Gastroenterologist, Patient, Researcher and Educator Perspectives” will provide attendees with the opportunity to learn not only about challenges faced by the LGBTQ+ community as patients, learners, and scientists, but how we as educators, researchers, clinicians, and leaders can strategically address these challenges and intentionally create inclusive spaces in an effort to reduce health care disparities and inequities in both clinical and academic environments.

A current initiative is the creation of an archive of notable underrepresented gastroenterologists and GI scientists. The database will serve as a resource for conference organizers and committee members to identify junior speakers and mentors from diverse minority, ethnic, and racial backgrounds. This will be a platform for divisional chairs, program directors, and mentors to recommend and promote upcoming stars in their designated fields. Once the website and cloud database have been built, the diversity committee will reach out to divisional chairs, program directors, committee members, and leaders in the field to recommend physicians and scientists to include in this database. We will then reach out to nominees with an invitation and link to complete their profile in the database. We believe that this will be an opportunity for young physicians and scientists and a resource to promote diversity in medicine and science.

While we share many common experiences as ethnic minorities, the gastroenterologists comprising the AGA Diversity Committee come from various cultural backgrounds, ethnicities, and clinical practice settings. Yet rather than creating contention, our differences are the strength of this committee. Our diverse backgrounds lead to a plethora of innovative ideas and perspectives in group discussions, resulting in very robust and productive meetings. In recognizing that a diverse group can render novel solutions to many topics and issues, one of our goals is to increase membership of underrepresented groups in the AGA, as well as participation in AGA committees. This entails direct outreach to gastroenterologists in these groups and acquainting them with the ways active participation in the numerous AGA committees will support the issues affecting their profession and patients.

The process of serving on an AGA committee is simple. Interested members can nominate themselves or be nominated by another AGA member and fill out a short application. The list of AGA committees, responsibilities, open positions, and application can be found at https://www.gastro.org/aga-leadership/committees. We believe committee participation is personally and professionally rewarding, and serving on the Diversity Committee is particularly gratifying, as we can address pertinent issues that may otherwise be neglected.

Dr. Badurdeen is assistant professor at Johns Hopkins Medicine, Columbia, Md; Dr. Charabaty Pishvaian is associate professor, clinical director of the GI division, and director of the IBD Center at Sibley Memorial Hospital, Washington; Dr. Malespin is assistant professor at the University of South Florida, Tampa, and transplant hepatologist, Tampa General Hospital; Dr. Oduyebo is a gastroenterologist for Mid-Atlantic Permanente Medical Group, Shady Grove, Md; Dr. Quezada is associate professor and assistant dean for academic and multicultural affairs, University of Maryland, Baltimore County; and Dr. Stephen is a gastroenterologist at Annadel Medical Group, Santa Rosa, Calif.
 

References

1. Oduyebo I et al. Underserved populations and colorectal cancer screening: Patient perceptions of barriers to care and effective interventions. GI & Hepatology News. May 2018.

2. Munroe CA et al. The AGA Diversity Committee: Opening up a conversation about unconscious bias in GI practice. AGA Perspectives. July 2019.

As gastroenterologists and gastrointestinal researchers, we work with an increasingly diverse patient population amid known disparities in health care delivery and health outcomes. The American Gastroenterological Association values diversity and inclusion, and part of its strategic plan is to increase and diversify its membership and leaders. The AGA Diversity Committee supports this strategic goal by fostering and promoting involvement, advancement, and recognition of underrepresented diverse constituencies. This is accomplished through policy recommendations and programs, providing resources to AGA members for addressing barriers to access and utilization of health care services among diverse patient populations with attention to linguistic, racial, cultural, religious, sexual orientation, gender identity, disability, age, and economic diversity.

There are eight clinician and investigator members, including the chair as well as one trainee member on the AGA Diversity Committee. Four members are appointed at-large and three members are appointed from the AGA Institute Committees and the AGA Institute Council. The committee has set out to achieve mission-driven goals with several initiatives that align with its intention to cultivate a diverse, inclusive, and engaged membership, armed with the necessary tools to provide the highest quality care and perform the most effective research that will benefit our patient population.

The communications task force highlights programs and topics that support the committee’s missions. Members of the committee coauthored a paper on colorectal disparities published in GI & Hepatology News in May 2018.¹ In addition to presenting the disparities in colorectal screening, it provided ways to close this gap. A more recent publication in AGA Perspectives focused on unconscious bias as a prelude to the committee’s workshop at Digestive Disease Week^® (DDW) 2019.² An important initiative has been promoting Black History Month in February and Pride Month in June by posting cases or displaying prominent trailblazers on the AGA Community. In the upcoming months, profiles of several committee members will be featured in eDigest, GI & Hepatology News, and on AGA’s social media platforms.

DDW programming sponsored by the Diversity Committee is an important way to engage our members. At DDW 2019, the committee sponsored a clinical symposium title “Beyond Starbucks: Mitigating Bias Through Awareness.” This session was inspired by the 2018 incidence hallmarked by the inappropriate arrest of two African American men at a Philadelphia Starbucks. This event led to a nationwide educational breakout for all employees aimed at providing unconscious bias training. The Diversity Committee drew inspiration from these events, holding a symposium with set goals of defining unconscious bias and identifying areas within health care where unconscious bias can influence patient care. The committee invited Allyson Dylan Robinson, a portfolio lead from the Association of American Medical Colleges–endorsed Cook Ross Firm, who is nationally recognized as a leader in unconscious bias training. The assembly began with an introductory lecture followed by breakout sessions where small groups reviewed selected patient cases to determine the influence of unconscious bias in clinical scenarios. It was a well-attended symposium and was complementary to the wide array of didactic lectures offered at DDW. Bringing to light significant issues and barriers to health care is one key aspect of the mission set forth by the Diversity Committee.

The AGA Diversity Committee e-poster tour at DDW 2019 promoted the research led by scientist and physician members of underrepresented groups in medicine and/or research focused on gastrointestinal diseases in underrepresented populations. Several high-quality abstracts were reviewed and four were selected for the e-poster tour. Each scientist presented their research in front of an enthusiastic audience of DDW attendees, followed by a question and answer session. Gonzalo Parodi, BS (Cedars-Sinai Medical Center, Los Angeles), presented an elegant study showing that the antibiotic changes to intestinal microbiome were sex specific in mice. Alexis Rivera, MD (University of Puerto Rico, San Juan), found no association between inflammatory bowel disease (IBD) serologic markers and risk of surgery in patients with IBD in Puerto Rico. Maria Gonzalez-Pons, PhD (University of Puerto Rico Comprehensive Cancer Center, San Juan), presented the first study looking at the mutational landscape of early-onset colorectal cancer tumors in Puerto Rican Hispanics, as a first step toward personalizing early screening in this population. Finally, Sushrut Jangi, MD (Brigham and Women’s Hospital, Boston), presented the first longitudinal study describing the unique demographic and phenotypic characteristics of IBD in South Asians living in the United States, showing that smoking was less relevant as a risk factor, and that Crohn’s presented with a more aggressive penetrating phenotype in this population. At the conclusion of the e-poster tour, attendees and presenters had the opportunity to exchange future research ideas or follow-up and network.

The upcoming DDW 2020 AGA Diversity Committee–sponsored symposium entitled “GI Health Disparities and Creating Affirming Environments for the LGBT+ Community: The Gastroenterologist, Patient, Researcher and Educator Perspectives” will provide attendees with the opportunity to learn not only about challenges faced by the LGBTQ+ community as patients, learners, and scientists, but how we as educators, researchers, clinicians, and leaders can strategically address these challenges and intentionally create inclusive spaces in an effort to reduce health care disparities and inequities in both clinical and academic environments.

A current initiative is the creation of an archive of notable underrepresented gastroenterologists and GI scientists. The database will serve as a resource for conference organizers and committee members to identify junior speakers and mentors from diverse minority, ethnic, and racial backgrounds. This will be a platform for divisional chairs, program directors, and mentors to recommend and promote upcoming stars in their designated fields. Once the website and cloud database have been built, the diversity committee will reach out to divisional chairs, program directors, committee members, and leaders in the field to recommend physicians and scientists to include in this database. We will then reach out to nominees with an invitation and link to complete their profile in the database. We believe that this will be an opportunity for young physicians and scientists and a resource to promote diversity in medicine and science.

While we share many common experiences as ethnic minorities, the gastroenterologists comprising the AGA Diversity Committee come from various cultural backgrounds, ethnicities, and clinical practice settings. Yet rather than creating contention, our differences are the strength of this committee. Our diverse backgrounds lead to a plethora of innovative ideas and perspectives in group discussions, resulting in very robust and productive meetings. In recognizing that a diverse group can render novel solutions to many topics and issues, one of our goals is to increase membership of underrepresented groups in the AGA, as well as participation in AGA committees. This entails direct outreach to gastroenterologists in these groups and acquainting them with the ways active participation in the numerous AGA committees will support the issues affecting their profession and patients.

The process of serving on an AGA committee is simple. Interested members can nominate themselves or be nominated by another AGA member and fill out a short application. The list of AGA committees, responsibilities, open positions, and application can be found at https://www.gastro.org/aga-leadership/committees. We believe committee participation is personally and professionally rewarding, and serving on the Diversity Committee is particularly gratifying, as we can address pertinent issues that may otherwise be neglected.

Dr. Badurdeen is assistant professor at Johns Hopkins Medicine, Columbia, Md; Dr. Charabaty Pishvaian is associate professor, clinical director of the GI division, and director of the IBD Center at Sibley Memorial Hospital, Washington; Dr. Malespin is assistant professor at the University of South Florida, Tampa, and transplant hepatologist, Tampa General Hospital; Dr. Oduyebo is a gastroenterologist for Mid-Atlantic Permanente Medical Group, Shady Grove, Md; Dr. Quezada is associate professor and assistant dean for academic and multicultural affairs, University of Maryland, Baltimore County; and Dr. Stephen is a gastroenterologist at Annadel Medical Group, Santa Rosa, Calif.
 

References

1. Oduyebo I et al. Underserved populations and colorectal cancer screening: Patient perceptions of barriers to care and effective interventions. GI & Hepatology News. May 2018.

2. Munroe CA et al. The AGA Diversity Committee: Opening up a conversation about unconscious bias in GI practice. AGA Perspectives. July 2019.

As gastroenterologists and gastrointestinal researchers, we work with an increasingly diverse patient population amid known disparities in health care delivery and health outcomes. The American Gastroenterological Association values diversity and inclusion, and part of its strategic plan is to increase and diversify its membership and leaders. The AGA Diversity Committee supports this strategic goal by fostering and promoting involvement, advancement, and recognition of underrepresented diverse constituencies. This is accomplished through policy recommendations and programs, providing resources to AGA members for addressing barriers to access and utilization of health care services among diverse patient populations with attention to linguistic, racial, cultural, religious, sexual orientation, gender identity, disability, age, and economic diversity.

There are eight clinician and investigator members, including the chair as well as one trainee member on the AGA Diversity Committee. Four members are appointed at-large and three members are appointed from the AGA Institute Committees and the AGA Institute Council. The committee has set out to achieve mission-driven goals with several initiatives that align with its intention to cultivate a diverse, inclusive, and engaged membership, armed with the necessary tools to provide the highest quality care and perform the most effective research that will benefit our patient population.

The communications task force highlights programs and topics that support the committee’s missions. Members of the committee coauthored a paper on colorectal disparities published in GI & Hepatology News in May 2018.¹ In addition to presenting the disparities in colorectal screening, it provided ways to close this gap. A more recent publication in AGA Perspectives focused on unconscious bias as a prelude to the committee’s workshop at Digestive Disease Week^® (DDW) 2019.² An important initiative has been promoting Black History Month in February and Pride Month in June by posting cases or displaying prominent trailblazers on the AGA Community. In the upcoming months, profiles of several committee members will be featured in eDigest, GI & Hepatology News, and on AGA’s social media platforms.

DDW programming sponsored by the Diversity Committee is an important way to engage our members. At DDW 2019, the committee sponsored a clinical symposium title “Beyond Starbucks: Mitigating Bias Through Awareness.” This session was inspired by the 2018 incidence hallmarked by the inappropriate arrest of two African American men at a Philadelphia Starbucks. This event led to a nationwide educational breakout for all employees aimed at providing unconscious bias training. The Diversity Committee drew inspiration from these events, holding a symposium with set goals of defining unconscious bias and identifying areas within health care where unconscious bias can influence patient care. The committee invited Allyson Dylan Robinson, a portfolio lead from the Association of American Medical Colleges–endorsed Cook Ross Firm, who is nationally recognized as a leader in unconscious bias training. The assembly began with an introductory lecture followed by breakout sessions where small groups reviewed selected patient cases to determine the influence of unconscious bias in clinical scenarios. It was a well-attended symposium and was complementary to the wide array of didactic lectures offered at DDW. Bringing to light significant issues and barriers to health care is one key aspect of the mission set forth by the Diversity Committee.

The AGA Diversity Committee e-poster tour at DDW 2019 promoted the research led by scientist and physician members of underrepresented groups in medicine and/or research focused on gastrointestinal diseases in underrepresented populations. Several high-quality abstracts were reviewed and four were selected for the e-poster tour. Each scientist presented their research in front of an enthusiastic audience of DDW attendees, followed by a question and answer session. Gonzalo Parodi, BS (Cedars-Sinai Medical Center, Los Angeles), presented an elegant study showing that the antibiotic changes to intestinal microbiome were sex specific in mice. Alexis Rivera, MD (University of Puerto Rico, San Juan), found no association between inflammatory bowel disease (IBD) serologic markers and risk of surgery in patients with IBD in Puerto Rico. Maria Gonzalez-Pons, PhD (University of Puerto Rico Comprehensive Cancer Center, San Juan), presented the first study looking at the mutational landscape of early-onset colorectal cancer tumors in Puerto Rican Hispanics, as a first step toward personalizing early screening in this population. Finally, Sushrut Jangi, MD (Brigham and Women’s Hospital, Boston), presented the first longitudinal study describing the unique demographic and phenotypic characteristics of IBD in South Asians living in the United States, showing that smoking was less relevant as a risk factor, and that Crohn’s presented with a more aggressive penetrating phenotype in this population. At the conclusion of the e-poster tour, attendees and presenters had the opportunity to exchange future research ideas or follow-up and network.

The upcoming DDW 2020 AGA Diversity Committee–sponsored symposium entitled “GI Health Disparities and Creating Affirming Environments for the LGBT+ Community: The Gastroenterologist, Patient, Researcher and Educator Perspectives” will provide attendees with the opportunity to learn not only about challenges faced by the LGBTQ+ community as patients, learners, and scientists, but how we as educators, researchers, clinicians, and leaders can strategically address these challenges and intentionally create inclusive spaces in an effort to reduce health care disparities and inequities in both clinical and academic environments.

A current initiative is the creation of an archive of notable underrepresented gastroenterologists and GI scientists. The database will serve as a resource for conference organizers and committee members to identify junior speakers and mentors from diverse minority, ethnic, and racial backgrounds. This will be a platform for divisional chairs, program directors, and mentors to recommend and promote upcoming stars in their designated fields. Once the website and cloud database have been built, the diversity committee will reach out to divisional chairs, program directors, committee members, and leaders in the field to recommend physicians and scientists to include in this database. We will then reach out to nominees with an invitation and link to complete their profile in the database. We believe that this will be an opportunity for young physicians and scientists and a resource to promote diversity in medicine and science.

While we share many common experiences as ethnic minorities, the gastroenterologists comprising the AGA Diversity Committee come from various cultural backgrounds, ethnicities, and clinical practice settings. Yet rather than creating contention, our differences are the strength of this committee. Our diverse backgrounds lead to a plethora of innovative ideas and perspectives in group discussions, resulting in very robust and productive meetings. In recognizing that a diverse group can render novel solutions to many topics and issues, one of our goals is to increase membership of underrepresented groups in the AGA, as well as participation in AGA committees. This entails direct outreach to gastroenterologists in these groups and acquainting them with the ways active participation in the numerous AGA committees will support the issues affecting their profession and patients.

The process of serving on an AGA committee is simple. Interested members can nominate themselves or be nominated by another AGA member and fill out a short application. The list of AGA committees, responsibilities, open positions, and application can be found at https://www.gastro.org/aga-leadership/committees. We believe committee participation is personally and professionally rewarding, and serving on the Diversity Committee is particularly gratifying, as we can address pertinent issues that may otherwise be neglected.

Dr. Badurdeen is assistant professor at Johns Hopkins Medicine, Columbia, Md; Dr. Charabaty Pishvaian is associate professor, clinical director of the GI division, and director of the IBD Center at Sibley Memorial Hospital, Washington; Dr. Malespin is assistant professor at the University of South Florida, Tampa, and transplant hepatologist, Tampa General Hospital; Dr. Oduyebo is a gastroenterologist for Mid-Atlantic Permanente Medical Group, Shady Grove, Md; Dr. Quezada is associate professor and assistant dean for academic and multicultural affairs, University of Maryland, Baltimore County; and Dr. Stephen is a gastroenterologist at Annadel Medical Group, Santa Rosa, Calif.
 

References

1. Oduyebo I et al. Underserved populations and colorectal cancer screening: Patient perceptions of barriers to care and effective interventions. GI & Hepatology News. May 2018.

2. Munroe CA et al. The AGA Diversity Committee: Opening up a conversation about unconscious bias in GI practice. AGA Perspectives. July 2019.

Digestive Disease Week (DDW) 2020, originally scheduled for May 2-5, 2020, in Chicago, has been canceled because of the coronavirus pandemic.

Organizers are exploring options for virtual presentation of some of the content material.

“While we are disappointed to miss the science, education, and networking that are hallmarks of DDW, we must focus on the health and safety of our community,” said DDW organizers in an email notification on March 18, 2020. “Thank you for your patience as we evaluated the status of DDW in light of the rapidly changing coronavirus pandemic.”

Citing the meeting’s long tradition of improving patient care and the understanding of digestive diseases, the organizers promised more information to come about opportunities for remote presentation of research and educational material.

All events associated with DDW are also canceled, said the email. A page of frequently asked questions is being maintained (https://digestivediseaseweek.freshdesk.com/support/solutions/43000366101), and questions may be asked by submitting a ticket to the DDW help desk (https://digestivediseaseweek.freshdesk.com/support/tickets/new).

[email protected]

Digestive Disease Week (DDW) 2020, originally scheduled for May 2-5, 2020, in Chicago, has been canceled because of the coronavirus pandemic.

Organizers are exploring options for virtual presentation of some of the content material.

“While we are disappointed to miss the science, education, and networking that are hallmarks of DDW, we must focus on the health and safety of our community,” said DDW organizers in an email notification on March 18, 2020. “Thank you for your patience as we evaluated the status of DDW in light of the rapidly changing coronavirus pandemic.”

Citing the meeting’s long tradition of improving patient care and the understanding of digestive diseases, the organizers promised more information to come about opportunities for remote presentation of research and educational material.

All events associated with DDW are also canceled, said the email. A page of frequently asked questions is being maintained (https://digestivediseaseweek.freshdesk.com/support/solutions/43000366101), and questions may be asked by submitting a ticket to the DDW help desk (https://digestivediseaseweek.freshdesk.com/support/tickets/new).

[email protected]

Digestive Disease Week (DDW) 2020, originally scheduled for May 2-5, 2020, in Chicago, has been canceled because of the coronavirus pandemic.

Organizers are exploring options for virtual presentation of some of the content material.

“While we are disappointed to miss the science, education, and networking that are hallmarks of DDW, we must focus on the health and safety of our community,” said DDW organizers in an email notification on March 18, 2020. “Thank you for your patience as we evaluated the status of DDW in light of the rapidly changing coronavirus pandemic.”

Citing the meeting’s long tradition of improving patient care and the understanding of digestive diseases, the organizers promised more information to come about opportunities for remote presentation of research and educational material.

All events associated with DDW are also canceled, said the email. A page of frequently asked questions is being maintained (https://digestivediseaseweek.freshdesk.com/support/solutions/43000366101), and questions may be asked by submitting a ticket to the DDW help desk (https://digestivediseaseweek.freshdesk.com/support/tickets/new).

[email protected]

A message from a Chief Wellness Officer

We are at a time, unfortunately, of significant public uncertainty and fear of “the coronavirus.” Mixed and inaccurate messages from national leaders in the setting of delayed testing availability have heightened fears and impeded a uniformity in responses, medical and preventive.

Despite this, physicians, nurses, and other health professionals across the country, and in many other countries, have been addressing the medical realities of this pandemic in a way that should make every one of us health professionals proud – from the Chinese doctors and nurses to the Italian intensivists and primary care physicians throughout many countries who have treated patients suffering from, or fearful of, a novel disease with uncertain transmission characteristics and unpredictable clinical outcomes.

It is now time for physicians and other health providers in the United States to step up to the plate and model appropriate transmission-reducing behavior for the general public. This will help reduce the overall morbidity and mortality associated with this pandemic and let us return to a more normal lifestyle as soon as possible. Physicians need to be reassuring but realistic, and there are concrete steps that we can take to demonstrate to the general public that there is a way forward.

First the basic facts. The United States does not have enough intensive care beds or ventilators to handle a major pandemic. We will also have insufficient physicians and nurses if many are quarantined. The tragic experience in Italy, where patients are dying from lack of ventilators, intensive care facilities, and staff, must not be repeated here.

Many health systems are canceling or reducing outpatient appointments and increasingly using video and other telehealth technologies, especially for assessing and triaging people who believe that they may have become infected and are relatively asymptomatic. While all of the disruptions may seem unsettling, they are actually good news for those of us in healthcare. Efforts to “flatten the curve” will slow the infection spread and help us better manage patients who become critical.

So, what can physicians do?

• Make sure you are getting good information about the situation. Access reliable information and data that are widely available through the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization. Listen to professional news organizations, local and national. Pass this information to your patients and community.
• Obviously, when practicing clinically, follow all infection control protocols, which will inevitably change over time. Make it clear to your patients why you are following these protocols and procedures.
• Support and actively promote the public health responses to this pandemic. Systematic reviews of the evidence base have found that isolating ill persons, testing and tracing contacts, quarantining exposed persons, closing schools and workplaces, and avoiding crowding are more effective if implemented immediately, simultaneously (ie, school closures combined with teleworking for parents), and with high community compliance.
• Practice social distancing so that you remain as much in control as you can. This will make you feel psychologically better and safer, as well as reduce the risk for transmission. Take the essential precautionary measures that we are all being asked to take. Wash your hands. Do not shake hands. Clean shared items. Do not go to large public gatherings. Minimize large group travel as much as you can. Use video to see your patients or your own doctor.
• Connect and reconnect with people you trust and love. See your family, your partner, your children, your friends. Speak to them on the phone and nourish those relationships. See how they feel and care for each other. They will be worried about you. Reassure them. Be in the moment with them and use the importance of these relationships to give yourself a chance not to overthink any fears you might have.
• Look after yourself physically. Physical fitness is good for your mental health. While White House guidelines suggest avoiding gyms, you can still enjoy long walks and outdoor activities. Take the weekend off and don’t work excessively. Sleep well – at least 7-8 hours. Yoga and tai chi are great for relaxation, as are some apps. One that I use personally is CBT-I Coach, a free app made by the VA for veterans, which has a series of really excellent meditation and relaxation tools.
• Do not panic. Uncertainty surrounding the pandemic makes all of us anxious and afraid. It is normal to become hypervigilant, especially with our nonstop media. It is normal to be concerned when we feel out of control and when we are hearing about a possible future catastrophe, especially when fed with differing sets of information from multiple sources and countries.
• Be careful with any large decisions you are making that may affect the lives of yourself and your loved ones. Think about your decisions and try to take the long view; and run them by your spouse, partner, or friends. This is not a time to be making sudden big decisions that may be driven unconsciously, in part at least, by fear and anxiety.
• Realize that all of these societal disruptions are actually good for us in health care, and they help your family and friends understand the importance of slowing the disease’s spread. That’s good for health care and good for everyone.

Finally, remember that “this is what we do,” to quote Doug Kirk, MD, chief medical officer of UC Davis Health. We must look after our patients. But we also have to look after ourselves so that we can look after our patients. We should all be proud of our work and our caring. And we should model our personal behavior to our patients and to our families and friends so that they will model it to their community networks. That way, more people will keep well, and we will have more chance of “flattening the curve” and reducing the morbidity and mortality associated with COVID-19.
 

Peter M. Yellowlees, MBBS, MD, is a professor in the Department of Psychiatry at the University of California, Davis. He is a longtime Medscape contributor.

This article first appeared on Medscape.com.

A message from a Chief Wellness Officer

We are at a time, unfortunately, of significant public uncertainty and fear of “the coronavirus.” Mixed and inaccurate messages from national leaders in the setting of delayed testing availability have heightened fears and impeded a uniformity in responses, medical and preventive.

Despite this, physicians, nurses, and other health professionals across the country, and in many other countries, have been addressing the medical realities of this pandemic in a way that should make every one of us health professionals proud – from the Chinese doctors and nurses to the Italian intensivists and primary care physicians throughout many countries who have treated patients suffering from, or fearful of, a novel disease with uncertain transmission characteristics and unpredictable clinical outcomes.

It is now time for physicians and other health providers in the United States to step up to the plate and model appropriate transmission-reducing behavior for the general public. This will help reduce the overall morbidity and mortality associated with this pandemic and let us return to a more normal lifestyle as soon as possible. Physicians need to be reassuring but realistic, and there are concrete steps that we can take to demonstrate to the general public that there is a way forward.

First the basic facts. The United States does not have enough intensive care beds or ventilators to handle a major pandemic. We will also have insufficient physicians and nurses if many are quarantined. The tragic experience in Italy, where patients are dying from lack of ventilators, intensive care facilities, and staff, must not be repeated here.

Many health systems are canceling or reducing outpatient appointments and increasingly using video and other telehealth technologies, especially for assessing and triaging people who believe that they may have become infected and are relatively asymptomatic. While all of the disruptions may seem unsettling, they are actually good news for those of us in healthcare. Efforts to “flatten the curve” will slow the infection spread and help us better manage patients who become critical.

So, what can physicians do?

• Make sure you are getting good information about the situation. Access reliable information and data that are widely available through the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization. Listen to professional news organizations, local and national. Pass this information to your patients and community.
• Obviously, when practicing clinically, follow all infection control protocols, which will inevitably change over time. Make it clear to your patients why you are following these protocols and procedures.
• Support and actively promote the public health responses to this pandemic. Systematic reviews of the evidence base have found that isolating ill persons, testing and tracing contacts, quarantining exposed persons, closing schools and workplaces, and avoiding crowding are more effective if implemented immediately, simultaneously (ie, school closures combined with teleworking for parents), and with high community compliance.
• Practice social distancing so that you remain as much in control as you can. This will make you feel psychologically better and safer, as well as reduce the risk for transmission. Take the essential precautionary measures that we are all being asked to take. Wash your hands. Do not shake hands. Clean shared items. Do not go to large public gatherings. Minimize large group travel as much as you can. Use video to see your patients or your own doctor.
• Connect and reconnect with people you trust and love. See your family, your partner, your children, your friends. Speak to them on the phone and nourish those relationships. See how they feel and care for each other. They will be worried about you. Reassure them. Be in the moment with them and use the importance of these relationships to give yourself a chance not to overthink any fears you might have.
• Look after yourself physically. Physical fitness is good for your mental health. While White House guidelines suggest avoiding gyms, you can still enjoy long walks and outdoor activities. Take the weekend off and don’t work excessively. Sleep well – at least 7-8 hours. Yoga and tai chi are great for relaxation, as are some apps. One that I use personally is CBT-I Coach, a free app made by the VA for veterans, which has a series of really excellent meditation and relaxation tools.
• Do not panic. Uncertainty surrounding the pandemic makes all of us anxious and afraid. It is normal to become hypervigilant, especially with our nonstop media. It is normal to be concerned when we feel out of control and when we are hearing about a possible future catastrophe, especially when fed with differing sets of information from multiple sources and countries.
• Be careful with any large decisions you are making that may affect the lives of yourself and your loved ones. Think about your decisions and try to take the long view; and run them by your spouse, partner, or friends. This is not a time to be making sudden big decisions that may be driven unconsciously, in part at least, by fear and anxiety.
• Realize that all of these societal disruptions are actually good for us in health care, and they help your family and friends understand the importance of slowing the disease’s spread. That’s good for health care and good for everyone.

Finally, remember that “this is what we do,” to quote Doug Kirk, MD, chief medical officer of UC Davis Health. We must look after our patients. But we also have to look after ourselves so that we can look after our patients. We should all be proud of our work and our caring. And we should model our personal behavior to our patients and to our families and friends so that they will model it to their community networks. That way, more people will keep well, and we will have more chance of “flattening the curve” and reducing the morbidity and mortality associated with COVID-19.
 

Peter M. Yellowlees, MBBS, MD, is a professor in the Department of Psychiatry at the University of California, Davis. He is a longtime Medscape contributor.

This article first appeared on Medscape.com.

A message from a Chief Wellness Officer

We are at a time, unfortunately, of significant public uncertainty and fear of “the coronavirus.” Mixed and inaccurate messages from national leaders in the setting of delayed testing availability have heightened fears and impeded a uniformity in responses, medical and preventive.

Despite this, physicians, nurses, and other health professionals across the country, and in many other countries, have been addressing the medical realities of this pandemic in a way that should make every one of us health professionals proud – from the Chinese doctors and nurses to the Italian intensivists and primary care physicians throughout many countries who have treated patients suffering from, or fearful of, a novel disease with uncertain transmission characteristics and unpredictable clinical outcomes.

It is now time for physicians and other health providers in the United States to step up to the plate and model appropriate transmission-reducing behavior for the general public. This will help reduce the overall morbidity and mortality associated with this pandemic and let us return to a more normal lifestyle as soon as possible. Physicians need to be reassuring but realistic, and there are concrete steps that we can take to demonstrate to the general public that there is a way forward.

First the basic facts. The United States does not have enough intensive care beds or ventilators to handle a major pandemic. We will also have insufficient physicians and nurses if many are quarantined. The tragic experience in Italy, where patients are dying from lack of ventilators, intensive care facilities, and staff, must not be repeated here.

Many health systems are canceling or reducing outpatient appointments and increasingly using video and other telehealth technologies, especially for assessing and triaging people who believe that they may have become infected and are relatively asymptomatic. While all of the disruptions may seem unsettling, they are actually good news for those of us in healthcare. Efforts to “flatten the curve” will slow the infection spread and help us better manage patients who become critical.

So, what can physicians do?

• Make sure you are getting good information about the situation. Access reliable information and data that are widely available through the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization. Listen to professional news organizations, local and national. Pass this information to your patients and community.
• Obviously, when practicing clinically, follow all infection control protocols, which will inevitably change over time. Make it clear to your patients why you are following these protocols and procedures.
• Support and actively promote the public health responses to this pandemic. Systematic reviews of the evidence base have found that isolating ill persons, testing and tracing contacts, quarantining exposed persons, closing schools and workplaces, and avoiding crowding are more effective if implemented immediately, simultaneously (ie, school closures combined with teleworking for parents), and with high community compliance.
• Practice social distancing so that you remain as much in control as you can. This will make you feel psychologically better and safer, as well as reduce the risk for transmission. Take the essential precautionary measures that we are all being asked to take. Wash your hands. Do not shake hands. Clean shared items. Do not go to large public gatherings. Minimize large group travel as much as you can. Use video to see your patients or your own doctor.
• Connect and reconnect with people you trust and love. See your family, your partner, your children, your friends. Speak to them on the phone and nourish those relationships. See how they feel and care for each other. They will be worried about you. Reassure them. Be in the moment with them and use the importance of these relationships to give yourself a chance not to overthink any fears you might have.
• Look after yourself physically. Physical fitness is good for your mental health. While White House guidelines suggest avoiding gyms, you can still enjoy long walks and outdoor activities. Take the weekend off and don’t work excessively. Sleep well – at least 7-8 hours. Yoga and tai chi are great for relaxation, as are some apps. One that I use personally is CBT-I Coach, a free app made by the VA for veterans, which has a series of really excellent meditation and relaxation tools.
• Do not panic. Uncertainty surrounding the pandemic makes all of us anxious and afraid. It is normal to become hypervigilant, especially with our nonstop media. It is normal to be concerned when we feel out of control and when we are hearing about a possible future catastrophe, especially when fed with differing sets of information from multiple sources and countries.
• Be careful with any large decisions you are making that may affect the lives of yourself and your loved ones. Think about your decisions and try to take the long view; and run them by your spouse, partner, or friends. This is not a time to be making sudden big decisions that may be driven unconsciously, in part at least, by fear and anxiety.
• Realize that all of these societal disruptions are actually good for us in health care, and they help your family and friends understand the importance of slowing the disease’s spread. That’s good for health care and good for everyone.

Finally, remember that “this is what we do,” to quote Doug Kirk, MD, chief medical officer of UC Davis Health. We must look after our patients. But we also have to look after ourselves so that we can look after our patients. We should all be proud of our work and our caring. And we should model our personal behavior to our patients and to our families and friends so that they will model it to their community networks. That way, more people will keep well, and we will have more chance of “flattening the curve” and reducing the morbidity and mortality associated with COVID-19.
 

Peter M. Yellowlees, MBBS, MD, is a professor in the Department of Psychiatry at the University of California, Davis. He is a longtime Medscape contributor.

This article first appeared on Medscape.com.

The Trump Administration is looking to telehealth services to play a more prominent role in helping mitigate the spread of COVID-19 by expanding existing benefits for Medicare beneficiaries.

“Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patients’ places of residence, starting March 6, 2020,” the Centers for Medicare & Medicaid Services said in a fact sheet issued March 17.

Some of the existing benefits were previously limited to rural communities.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” CMS Administrator Seema Verma said during a March 17 White House press briefing on administration actions to contain the spread of COVID-19. “These services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

That means that seniors can continue to receive their routine care without having to leave the home and risk infection, or they can get medical guidance if they have mild symptoms, which would help mitigate the spread to others.

“This shift is very important for clinicians and providers who, over the coming weeks, will face considerable strain on their time and resources,” Dr. Verma said. “[It] allows the health care system to prioritize care for those who have more needs or who are in dire need, and it also preserves protective equipment.”

A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office.

This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.

“In addition, the [Health and Human Services’] office of inspector general is providing flexibility for health care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care programs,” the fact sheet states. CMS also said it will not conduct audits to ensure that an established relationship exists between the provider and the patient – a prior requirement for telehealth billing – during this public health emergency.

Billing for virtual check-ins, which are essentially brief conversations that may not require a full visit to the physician office, needs an established relationship between the practice and the patient. Likewise, for e-visits, which include non–face-to-face communications through online patient portals, billing can occur only when there is an established patient relationship.

Key to the expansion is that it will cover the entire United States and will not be limited to rural areas.

Dr. Verma also noted that the administration “will be temporarily suspending certain HIPAA requirements so that doctors can provide telehealth with their own phones.”

She noted this was all a part of mitigation efforts to limit the spread of COVID-19.

“As we are encouraging Americans to stay home whenever possible, we don’t want our Medicare policies getting in the way,” she said, adding that state Medicaid agencies can expand their telehealth services without the approval of CMS during this emergency.

[email protected]

The Trump Administration is looking to telehealth services to play a more prominent role in helping mitigate the spread of COVID-19 by expanding existing benefits for Medicare beneficiaries.

“Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patients’ places of residence, starting March 6, 2020,” the Centers for Medicare & Medicaid Services said in a fact sheet issued March 17.

Some of the existing benefits were previously limited to rural communities.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” CMS Administrator Seema Verma said during a March 17 White House press briefing on administration actions to contain the spread of COVID-19. “These services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

That means that seniors can continue to receive their routine care without having to leave the home and risk infection, or they can get medical guidance if they have mild symptoms, which would help mitigate the spread to others.

“This shift is very important for clinicians and providers who, over the coming weeks, will face considerable strain on their time and resources,” Dr. Verma said. “[It] allows the health care system to prioritize care for those who have more needs or who are in dire need, and it also preserves protective equipment.”

A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office.

This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.

“In addition, the [Health and Human Services’] office of inspector general is providing flexibility for health care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care programs,” the fact sheet states. CMS also said it will not conduct audits to ensure that an established relationship exists between the provider and the patient – a prior requirement for telehealth billing – during this public health emergency.

Billing for virtual check-ins, which are essentially brief conversations that may not require a full visit to the physician office, needs an established relationship between the practice and the patient. Likewise, for e-visits, which include non–face-to-face communications through online patient portals, billing can occur only when there is an established patient relationship.

Key to the expansion is that it will cover the entire United States and will not be limited to rural areas.

Dr. Verma also noted that the administration “will be temporarily suspending certain HIPAA requirements so that doctors can provide telehealth with their own phones.”

She noted this was all a part of mitigation efforts to limit the spread of COVID-19.

“As we are encouraging Americans to stay home whenever possible, we don’t want our Medicare policies getting in the way,” she said, adding that state Medicaid agencies can expand their telehealth services without the approval of CMS during this emergency.

[email protected]

The Trump Administration is looking to telehealth services to play a more prominent role in helping mitigate the spread of COVID-19 by expanding existing benefits for Medicare beneficiaries.

“Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patients’ places of residence, starting March 6, 2020,” the Centers for Medicare & Medicaid Services said in a fact sheet issued March 17.

Some of the existing benefits were previously limited to rural communities.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” CMS Administrator Seema Verma said during a March 17 White House press briefing on administration actions to contain the spread of COVID-19. “These services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

That means that seniors can continue to receive their routine care without having to leave the home and risk infection, or they can get medical guidance if they have mild symptoms, which would help mitigate the spread to others.

“This shift is very important for clinicians and providers who, over the coming weeks, will face considerable strain on their time and resources,” Dr. Verma said. “[It] allows the health care system to prioritize care for those who have more needs or who are in dire need, and it also preserves protective equipment.”

A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office.

This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.

“In addition, the [Health and Human Services’] office of inspector general is providing flexibility for health care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care programs,” the fact sheet states. CMS also said it will not conduct audits to ensure that an established relationship exists between the provider and the patient – a prior requirement for telehealth billing – during this public health emergency.

Billing for virtual check-ins, which are essentially brief conversations that may not require a full visit to the physician office, needs an established relationship between the practice and the patient. Likewise, for e-visits, which include non–face-to-face communications through online patient portals, billing can occur only when there is an established patient relationship.

Key to the expansion is that it will cover the entire United States and will not be limited to rural areas.

Dr. Verma also noted that the administration “will be temporarily suspending certain HIPAA requirements so that doctors can provide telehealth with their own phones.”

She noted this was all a part of mitigation efforts to limit the spread of COVID-19.

“As we are encouraging Americans to stay home whenever possible, we don’t want our Medicare policies getting in the way,” she said, adding that state Medicaid agencies can expand their telehealth services without the approval of CMS during this emergency.

[email protected]

In this edition of “Applying research to practice,” I highlight a study revealing real-world information about the clinical care of breast cancer patients with deleterious germline mutations.

While germline testing among breast cancer patients is becoming more commonplace, it isn’t clear how test results influence patient care. To gain some insight, Allison W. Kurian, MD, of Stanford (Calif.) University, and colleagues analyzed data on 20,568 women with stage 0-III breast cancer from the Surveillance, Epidemiology, and End Results (SEER) registries of Georgia and California (JAMA Oncol. 2020 Feb 6. doi: 10.1001/jamaoncol.2019.6400).

The researchers aimed to determine whether women with mutations in breast cancer–associated genes (BRCA1/2 or others) received guideline-concordant care to the same degree as women who lacked deleterious mutations. The authors evaluated guideline concordance with respect to three treatment modalities: surgery (bilateral vs. unilateral mastectomy in women who were eligible for unilateral surgery), radiotherapy after lumpectomy (for women aged less than 70 years with hormonally responsive, ErbB2-negative, stage I cancers), and chemotherapy (among women eligible for consideration of chemotherapy omission)

In alignment with guidelines, many clinicians correctly used genetic test results to guide surgical decisions. For example, 61.7% of women with BRCA mutations underwent bilateral mastectomy, compared with 24.3% who were mutation negative (odds ratio, 5.52). For other pathogenic variants (ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, and TP53), the rate of bilateral mastectomy was still elevated, albeit to a lesser degree (OR, 2.41).

In discord with guidelines, women with BRCA mutations were 78% less likely to receive radiotherapy after lumpectomy (OR, 0.22) and 76% more likely to receive chemotherapy for early-stage, hormone-positive disease (OR, 1.76), suggesting possible trends in under- and overtreatment, respectively. Chemotherapy utilization rates among mutation carriers and noncarriers became more similar after adjustment for clinical and demographic factors.

There are limits on the granularity of the SEER database, such that, if a patient had a mastectomy a year or more after lumpectomy in an effort to avoid radiotherapy, the database would not have reflected that. Clinical factors could have appropriately influenced chemotherapy receipt among patients with mutations, but those additional factors (including patient preference) would not be included in the SEER data.

The authors concluded that research should be conducted to confirm the results of this retrospective, population-based cohort analysis, in an effort to understand the decision-making process and consequences for long-term outcome.
 

How these findings should influence practice

With every new development, there are challenges – some expected, some unanticipated.

It is now feasible to obtain multigene panel testing reasonably inexpensively. There are concerns about undertesting of patients on the basis of family history alone. And some major professional organizations have endorsed routine gene panel testing for all breast cancer patients.

As a consequence of these factors, genetic test results are routinely available to clinicians who may lack formal training in clinical genetics. Whether these results influence the receipt of evidence-based clinical care is uncertain.

The information published by Dr. Kurian and colleagues is inherently limited by the methodology of a SEER database review. Among other limitations, as the authors comment:

• The genetic test results could have arrived after treatment decisions were made.
• Treatment delivered more than a year after diagnosis would not have been captured.
• There was selection of patients for genetic testing.
• There were few patients with particular germline mutations other than BRCA1/2 on whom to judge whether treatment was guideline concordant.
• The rationale for the treatment choices made by physicians and patients was not available.
• Impact of treatment choices on survival for carriers of deleterious mutations is uncertain.

Nonetheless, these data suggest a need to redouble efforts to educate patients, their family members, and health care professionals about evidence-based guidelines for care and the rationale for those recommendations.

Careful, prospective monitoring of any resultant differences in treatment outcome in patients treated with guideline-concordant and nonconcordant care is needed. When treatment choices appear to systematically deviate from published guidelines with no obvious rationale, it is a wake-up call for all of us.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations.

In this edition of “Applying research to practice,” I highlight a study revealing real-world information about the clinical care of breast cancer patients with deleterious germline mutations.

While germline testing among breast cancer patients is becoming more commonplace, it isn’t clear how test results influence patient care. To gain some insight, Allison W. Kurian, MD, of Stanford (Calif.) University, and colleagues analyzed data on 20,568 women with stage 0-III breast cancer from the Surveillance, Epidemiology, and End Results (SEER) registries of Georgia and California (JAMA Oncol. 2020 Feb 6. doi: 10.1001/jamaoncol.2019.6400).

The researchers aimed to determine whether women with mutations in breast cancer–associated genes (BRCA1/2 or others) received guideline-concordant care to the same degree as women who lacked deleterious mutations. The authors evaluated guideline concordance with respect to three treatment modalities: surgery (bilateral vs. unilateral mastectomy in women who were eligible for unilateral surgery), radiotherapy after lumpectomy (for women aged less than 70 years with hormonally responsive, ErbB2-negative, stage I cancers), and chemotherapy (among women eligible for consideration of chemotherapy omission)

In alignment with guidelines, many clinicians correctly used genetic test results to guide surgical decisions. For example, 61.7% of women with BRCA mutations underwent bilateral mastectomy, compared with 24.3% who were mutation negative (odds ratio, 5.52). For other pathogenic variants (ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, and TP53), the rate of bilateral mastectomy was still elevated, albeit to a lesser degree (OR, 2.41).

In discord with guidelines, women with BRCA mutations were 78% less likely to receive radiotherapy after lumpectomy (OR, 0.22) and 76% more likely to receive chemotherapy for early-stage, hormone-positive disease (OR, 1.76), suggesting possible trends in under- and overtreatment, respectively. Chemotherapy utilization rates among mutation carriers and noncarriers became more similar after adjustment for clinical and demographic factors.

There are limits on the granularity of the SEER database, such that, if a patient had a mastectomy a year or more after lumpectomy in an effort to avoid radiotherapy, the database would not have reflected that. Clinical factors could have appropriately influenced chemotherapy receipt among patients with mutations, but those additional factors (including patient preference) would not be included in the SEER data.

The authors concluded that research should be conducted to confirm the results of this retrospective, population-based cohort analysis, in an effort to understand the decision-making process and consequences for long-term outcome.
 

How these findings should influence practice

With every new development, there are challenges – some expected, some unanticipated.

It is now feasible to obtain multigene panel testing reasonably inexpensively. There are concerns about undertesting of patients on the basis of family history alone. And some major professional organizations have endorsed routine gene panel testing for all breast cancer patients.

As a consequence of these factors, genetic test results are routinely available to clinicians who may lack formal training in clinical genetics. Whether these results influence the receipt of evidence-based clinical care is uncertain.

The information published by Dr. Kurian and colleagues is inherently limited by the methodology of a SEER database review. Among other limitations, as the authors comment:

• The genetic test results could have arrived after treatment decisions were made.
• Treatment delivered more than a year after diagnosis would not have been captured.
• There was selection of patients for genetic testing.
• There were few patients with particular germline mutations other than BRCA1/2 on whom to judge whether treatment was guideline concordant.
• The rationale for the treatment choices made by physicians and patients was not available.
• Impact of treatment choices on survival for carriers of deleterious mutations is uncertain.

Nonetheless, these data suggest a need to redouble efforts to educate patients, their family members, and health care professionals about evidence-based guidelines for care and the rationale for those recommendations.

Careful, prospective monitoring of any resultant differences in treatment outcome in patients treated with guideline-concordant and nonconcordant care is needed. When treatment choices appear to systematically deviate from published guidelines with no obvious rationale, it is a wake-up call for all of us.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations.

In this edition of “Applying research to practice,” I highlight a study revealing real-world information about the clinical care of breast cancer patients with deleterious germline mutations.

While germline testing among breast cancer patients is becoming more commonplace, it isn’t clear how test results influence patient care. To gain some insight, Allison W. Kurian, MD, of Stanford (Calif.) University, and colleagues analyzed data on 20,568 women with stage 0-III breast cancer from the Surveillance, Epidemiology, and End Results (SEER) registries of Georgia and California (JAMA Oncol. 2020 Feb 6. doi: 10.1001/jamaoncol.2019.6400).

The researchers aimed to determine whether women with mutations in breast cancer–associated genes (BRCA1/2 or others) received guideline-concordant care to the same degree as women who lacked deleterious mutations. The authors evaluated guideline concordance with respect to three treatment modalities: surgery (bilateral vs. unilateral mastectomy in women who were eligible for unilateral surgery), radiotherapy after lumpectomy (for women aged less than 70 years with hormonally responsive, ErbB2-negative, stage I cancers), and chemotherapy (among women eligible for consideration of chemotherapy omission)

In alignment with guidelines, many clinicians correctly used genetic test results to guide surgical decisions. For example, 61.7% of women with BRCA mutations underwent bilateral mastectomy, compared with 24.3% who were mutation negative (odds ratio, 5.52). For other pathogenic variants (ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, and TP53), the rate of bilateral mastectomy was still elevated, albeit to a lesser degree (OR, 2.41).

In discord with guidelines, women with BRCA mutations were 78% less likely to receive radiotherapy after lumpectomy (OR, 0.22) and 76% more likely to receive chemotherapy for early-stage, hormone-positive disease (OR, 1.76), suggesting possible trends in under- and overtreatment, respectively. Chemotherapy utilization rates among mutation carriers and noncarriers became more similar after adjustment for clinical and demographic factors.

There are limits on the granularity of the SEER database, such that, if a patient had a mastectomy a year or more after lumpectomy in an effort to avoid radiotherapy, the database would not have reflected that. Clinical factors could have appropriately influenced chemotherapy receipt among patients with mutations, but those additional factors (including patient preference) would not be included in the SEER data.

The authors concluded that research should be conducted to confirm the results of this retrospective, population-based cohort analysis, in an effort to understand the decision-making process and consequences for long-term outcome.
 

How these findings should influence practice

With every new development, there are challenges – some expected, some unanticipated.

It is now feasible to obtain multigene panel testing reasonably inexpensively. There are concerns about undertesting of patients on the basis of family history alone. And some major professional organizations have endorsed routine gene panel testing for all breast cancer patients.

As a consequence of these factors, genetic test results are routinely available to clinicians who may lack formal training in clinical genetics. Whether these results influence the receipt of evidence-based clinical care is uncertain.

The information published by Dr. Kurian and colleagues is inherently limited by the methodology of a SEER database review. Among other limitations, as the authors comment:

• The genetic test results could have arrived after treatment decisions were made.
• Treatment delivered more than a year after diagnosis would not have been captured.
• There was selection of patients for genetic testing.
• There were few patients with particular germline mutations other than BRCA1/2 on whom to judge whether treatment was guideline concordant.
• The rationale for the treatment choices made by physicians and patients was not available.
• Impact of treatment choices on survival for carriers of deleterious mutations is uncertain.

Nonetheless, these data suggest a need to redouble efforts to educate patients, their family members, and health care professionals about evidence-based guidelines for care and the rationale for those recommendations.

Careful, prospective monitoring of any resultant differences in treatment outcome in patients treated with guideline-concordant and nonconcordant care is needed. When treatment choices appear to systematically deviate from published guidelines with no obvious rationale, it is a wake-up call for all of us.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations.

KENT, WASHINGTON – The first thing I learned in this outbreak is that my sense of alarm has been deadened by years of medical practice. As a primary care doctor working south of Seattle, in the University of Washington’s Kent neighborhood clinic, I have dealt with long hours, the sometimes-insurmountable problems of the patients I care for, and the constant, gnawing fear of missing something and doing harm. To get through my day, I’ve done my best to rationalize that fear, to explain it away.

I can’t explain how, when I heard the news of the coronavirus epidemic in China, I didn’t think it would affect me. I can’t explain how news of the first patient presenting to an urgent care north of Seattle didn’t cause me, or all health care providers, to think about how we would respond. I can’t explain why so many doctors were dismissive of the very real threat that was about to explode. I can’t explain why it took 6 weeks for the COVID-19 outbreak to seem real to me.

If you work in a doctor’s office, emergency department, hospital, or urgent care center and have not seen a coronavirus case yet, you may have time to think through what is likely to happen in your community. After Washington state’s first case of COVID-19 became publicly known, few health care workers or leaders took the opportunity to work on our protocols, run drills, and check our supplies. We did not activate a chain of command or decide how information was going to be communicated to the front line and back to leadership. Few of us ran worst-case scenarios.

By March 12, we had 376 confirmed cases, and likely more than a thousand are undetected. The moment of realization of the severity of the outbreak didn’t come to me until Saturday, Feb. 29. In the week prior, several patients had come into the clinic with symptoms and potential exposures, but not meeting the narrow Centers for Disease Control and Prevention testing criteria. They were all advised by the Washington Department of Health to go home. At the time, it seemed like decent advice. Frontline providers didn’t know that there had been two cases of community transmission weeks before, or that one was about to become the first death in Washington state. I still advised patients to quarantine themselves. In the absence of testing, we had to assume everyone was positive and should stay home until 72 hours after their symptoms resolved. Studying the state’s FMLA [Family and Medical Leave Act] intently, I wrote insistent letters to inflexible bosses, explaining that their employees needed to stay home.

I worked that Saturday. Half of my patients had coughs. Our team insisted that they wear masks. One woman refused, and I refused to see her until she did. In a customer service–oriented health care system, I had been schooled to accommodate almost any patient request. But I was not about to put my staff and other patients at risk. Reluctantly, she complied.

On my lunch break, my partner called me to tell me he was at the grocery store. “Why?” I asked, since we usually went together. It became clear he was worried about an outbreak. He had been following the news closely and tried to tell me how deadly this could get and how quickly the disease could spread. I brushed his fears aside, as more evidence of his sweet and overly cautious nature. “It’ll be fine,” I said with misplaced confidence.

Later that day, I heard about the first death and the outbreak at Life Care, a nursing home north of Seattle. I learned that firefighters who had responded to distress calls were under quarantine. I learned through an epidemiologist that there were likely hundreds of undetected cases throughout Washington.

On Monday, our clinic decided to convert all cases with symptoms into telemedicine visits. Luckily, we had been building the capacity to see and treat patients virtually for a while. We have ramped up quickly, but there have been bumps along the way. It’s difficult to convince those who are anxious about their symptoms to allow us to use telemedicine for everyone’s safety. It is unclear how much liability we are taking on as individual providers with this approach or who will speak up for us if something goes wrong.

Patients don’t seem to know where to get their information, and they have been turning to increasingly bizarre sources. For the poorest, who have had so much trouble accessing care, I cannot blame them for not knowing whom to trust. I post what I know on Twitter and Facebook, but I know I’m no match for cynical social media algorithms.

Testing was still not available at my clinic the first week of March, and it remains largely unavailable throughout much of the country. We have lost weeks of opportunity to contain this. Luckily, on March 4, the University of Washington was finally allowed to use their homegrown test and bypass the limited supply from the CDC. But our capacity at UW is still limited, and the test remained unavailable to the majority of those potentially showing symptoms until March 9.

I am used to being less worried than my patients. I am used to reassuring them. But over the first week of March, I had an eerie sense that my alarm far outstripped theirs. I got relatively few questions about coronavirus, even as the number of cases continued to rise. It wasn’t until the end of the week that I noticed a few were truly fearful. Patients started stealing the gloves and the hand sanitizer, and we had to zealously guard them. My hands are raw from washing.

Throughout this time, I have been grateful for a centralized drive with clear protocols. I am grateful for clear messages at the beginning and end of the day from our CEO. I hope that other clinics model this and have daily in-person meetings, because too much cannot be conveyed in an email when the situation changes hourly.

But our health system nationally was already stretched thin before, and providers have sacrificed a lot, especially in the most critical settings, to provide decent patient care. Now we are asked to risk our health and safety, and our family’s, and I worry about the erosion of trust and work conditions for those on the front lines. I also worry our patients won’t believe us when we have allowed the costs of care to continue to rise and ruin their lives. I worry about the millions of people without doctors to call because they have no insurance, and because so many primary care physicians have left unsustainable jobs.

I am grateful that few of my colleagues have been sick and that those that were called out. I am grateful for the new nurse practitioners in our clinic who took the lion’s share of possibly affected patients and triaged hundreds of phone calls, creating note and message templates that we all use. I am grateful that my clinic manager insisted on doing a drill with all the staff members.

I am grateful that we were reminded that we are a team and that if the call center and cleaning crews and front desk are excluded, then our protocols are useless. I am grateful that our registered nurses quickly shifted to triage. I am grateful that I have testing available.

This week, for the first time since I started working, multiple patients asked how I am doing and expressed their thanks. I am most grateful for them.

I can’t tell you what to do or what is going to happen, but I can tell you that you need to prepare now. You need to run drills and catch the holes in your plans before the pandemic reaches you. You need to be creative and honest about the flaws in your organization that this pandemic will inevitably expose. You need to meet with your team every day and remember that we are all going to be stretched even thinner than before.

Most of us will get through this, but many of us won’t. And for those who do, we need to be honest about our successes and failures. We need to build a system that can do better next time. Because this is not the last pandemic we will face.
 

Dr. Elisabeth Poorman is a general internist at a University of Washington neighborhood clinic in Kent. She completed her residency at Cambridge (Mass.) Health Alliance and specializes in addiction medicine. She also serves on the editorial advisory board of Internal Medicine News.

KENT, WASHINGTON – The first thing I learned in this outbreak is that my sense of alarm has been deadened by years of medical practice. As a primary care doctor working south of Seattle, in the University of Washington’s Kent neighborhood clinic, I have dealt with long hours, the sometimes-insurmountable problems of the patients I care for, and the constant, gnawing fear of missing something and doing harm. To get through my day, I’ve done my best to rationalize that fear, to explain it away.

I can’t explain how, when I heard the news of the coronavirus epidemic in China, I didn’t think it would affect me. I can’t explain how news of the first patient presenting to an urgent care north of Seattle didn’t cause me, or all health care providers, to think about how we would respond. I can’t explain why so many doctors were dismissive of the very real threat that was about to explode. I can’t explain why it took 6 weeks for the COVID-19 outbreak to seem real to me.

If you work in a doctor’s office, emergency department, hospital, or urgent care center and have not seen a coronavirus case yet, you may have time to think through what is likely to happen in your community. After Washington state’s first case of COVID-19 became publicly known, few health care workers or leaders took the opportunity to work on our protocols, run drills, and check our supplies. We did not activate a chain of command or decide how information was going to be communicated to the front line and back to leadership. Few of us ran worst-case scenarios.

By March 12, we had 376 confirmed cases, and likely more than a thousand are undetected. The moment of realization of the severity of the outbreak didn’t come to me until Saturday, Feb. 29. In the week prior, several patients had come into the clinic with symptoms and potential exposures, but not meeting the narrow Centers for Disease Control and Prevention testing criteria. They were all advised by the Washington Department of Health to go home. At the time, it seemed like decent advice. Frontline providers didn’t know that there had been two cases of community transmission weeks before, or that one was about to become the first death in Washington state. I still advised patients to quarantine themselves. In the absence of testing, we had to assume everyone was positive and should stay home until 72 hours after their symptoms resolved. Studying the state’s FMLA [Family and Medical Leave Act] intently, I wrote insistent letters to inflexible bosses, explaining that their employees needed to stay home.

I worked that Saturday. Half of my patients had coughs. Our team insisted that they wear masks. One woman refused, and I refused to see her until she did. In a customer service–oriented health care system, I had been schooled to accommodate almost any patient request. But I was not about to put my staff and other patients at risk. Reluctantly, she complied.

On my lunch break, my partner called me to tell me he was at the grocery store. “Why?” I asked, since we usually went together. It became clear he was worried about an outbreak. He had been following the news closely and tried to tell me how deadly this could get and how quickly the disease could spread. I brushed his fears aside, as more evidence of his sweet and overly cautious nature. “It’ll be fine,” I said with misplaced confidence.

Later that day, I heard about the first death and the outbreak at Life Care, a nursing home north of Seattle. I learned that firefighters who had responded to distress calls were under quarantine. I learned through an epidemiologist that there were likely hundreds of undetected cases throughout Washington.

On Monday, our clinic decided to convert all cases with symptoms into telemedicine visits. Luckily, we had been building the capacity to see and treat patients virtually for a while. We have ramped up quickly, but there have been bumps along the way. It’s difficult to convince those who are anxious about their symptoms to allow us to use telemedicine for everyone’s safety. It is unclear how much liability we are taking on as individual providers with this approach or who will speak up for us if something goes wrong.

Patients don’t seem to know where to get their information, and they have been turning to increasingly bizarre sources. For the poorest, who have had so much trouble accessing care, I cannot blame them for not knowing whom to trust. I post what I know on Twitter and Facebook, but I know I’m no match for cynical social media algorithms.

Testing was still not available at my clinic the first week of March, and it remains largely unavailable throughout much of the country. We have lost weeks of opportunity to contain this. Luckily, on March 4, the University of Washington was finally allowed to use their homegrown test and bypass the limited supply from the CDC. But our capacity at UW is still limited, and the test remained unavailable to the majority of those potentially showing symptoms until March 9.

I am used to being less worried than my patients. I am used to reassuring them. But over the first week of March, I had an eerie sense that my alarm far outstripped theirs. I got relatively few questions about coronavirus, even as the number of cases continued to rise. It wasn’t until the end of the week that I noticed a few were truly fearful. Patients started stealing the gloves and the hand sanitizer, and we had to zealously guard them. My hands are raw from washing.

Throughout this time, I have been grateful for a centralized drive with clear protocols. I am grateful for clear messages at the beginning and end of the day from our CEO. I hope that other clinics model this and have daily in-person meetings, because too much cannot be conveyed in an email when the situation changes hourly.

But our health system nationally was already stretched thin before, and providers have sacrificed a lot, especially in the most critical settings, to provide decent patient care. Now we are asked to risk our health and safety, and our family’s, and I worry about the erosion of trust and work conditions for those on the front lines. I also worry our patients won’t believe us when we have allowed the costs of care to continue to rise and ruin their lives. I worry about the millions of people without doctors to call because they have no insurance, and because so many primary care physicians have left unsustainable jobs.

I am grateful that few of my colleagues have been sick and that those that were called out. I am grateful for the new nurse practitioners in our clinic who took the lion’s share of possibly affected patients and triaged hundreds of phone calls, creating note and message templates that we all use. I am grateful that my clinic manager insisted on doing a drill with all the staff members.

I am grateful that we were reminded that we are a team and that if the call center and cleaning crews and front desk are excluded, then our protocols are useless. I am grateful that our registered nurses quickly shifted to triage. I am grateful that I have testing available.

This week, for the first time since I started working, multiple patients asked how I am doing and expressed their thanks. I am most grateful for them.

I can’t tell you what to do or what is going to happen, but I can tell you that you need to prepare now. You need to run drills and catch the holes in your plans before the pandemic reaches you. You need to be creative and honest about the flaws in your organization that this pandemic will inevitably expose. You need to meet with your team every day and remember that we are all going to be stretched even thinner than before.

Most of us will get through this, but many of us won’t. And for those who do, we need to be honest about our successes and failures. We need to build a system that can do better next time. Because this is not the last pandemic we will face.
 

Dr. Elisabeth Poorman is a general internist at a University of Washington neighborhood clinic in Kent. She completed her residency at Cambridge (Mass.) Health Alliance and specializes in addiction medicine. She also serves on the editorial advisory board of Internal Medicine News.

KENT, WASHINGTON – The first thing I learned in this outbreak is that my sense of alarm has been deadened by years of medical practice. As a primary care doctor working south of Seattle, in the University of Washington’s Kent neighborhood clinic, I have dealt with long hours, the sometimes-insurmountable problems of the patients I care for, and the constant, gnawing fear of missing something and doing harm. To get through my day, I’ve done my best to rationalize that fear, to explain it away.

I can’t explain how, when I heard the news of the coronavirus epidemic in China, I didn’t think it would affect me. I can’t explain how news of the first patient presenting to an urgent care north of Seattle didn’t cause me, or all health care providers, to think about how we would respond. I can’t explain why so many doctors were dismissive of the very real threat that was about to explode. I can’t explain why it took 6 weeks for the COVID-19 outbreak to seem real to me.

If you work in a doctor’s office, emergency department, hospital, or urgent care center and have not seen a coronavirus case yet, you may have time to think through what is likely to happen in your community. After Washington state’s first case of COVID-19 became publicly known, few health care workers or leaders took the opportunity to work on our protocols, run drills, and check our supplies. We did not activate a chain of command or decide how information was going to be communicated to the front line and back to leadership. Few of us ran worst-case scenarios.

By March 12, we had 376 confirmed cases, and likely more than a thousand are undetected. The moment of realization of the severity of the outbreak didn’t come to me until Saturday, Feb. 29. In the week prior, several patients had come into the clinic with symptoms and potential exposures, but not meeting the narrow Centers for Disease Control and Prevention testing criteria. They were all advised by the Washington Department of Health to go home. At the time, it seemed like decent advice. Frontline providers didn’t know that there had been two cases of community transmission weeks before, or that one was about to become the first death in Washington state. I still advised patients to quarantine themselves. In the absence of testing, we had to assume everyone was positive and should stay home until 72 hours after their symptoms resolved. Studying the state’s FMLA [Family and Medical Leave Act] intently, I wrote insistent letters to inflexible bosses, explaining that their employees needed to stay home.

I worked that Saturday. Half of my patients had coughs. Our team insisted that they wear masks. One woman refused, and I refused to see her until she did. In a customer service–oriented health care system, I had been schooled to accommodate almost any patient request. But I was not about to put my staff and other patients at risk. Reluctantly, she complied.

On my lunch break, my partner called me to tell me he was at the grocery store. “Why?” I asked, since we usually went together. It became clear he was worried about an outbreak. He had been following the news closely and tried to tell me how deadly this could get and how quickly the disease could spread. I brushed his fears aside, as more evidence of his sweet and overly cautious nature. “It’ll be fine,” I said with misplaced confidence.

Later that day, I heard about the first death and the outbreak at Life Care, a nursing home north of Seattle. I learned that firefighters who had responded to distress calls were under quarantine. I learned through an epidemiologist that there were likely hundreds of undetected cases throughout Washington.

On Monday, our clinic decided to convert all cases with symptoms into telemedicine visits. Luckily, we had been building the capacity to see and treat patients virtually for a while. We have ramped up quickly, but there have been bumps along the way. It’s difficult to convince those who are anxious about their symptoms to allow us to use telemedicine for everyone’s safety. It is unclear how much liability we are taking on as individual providers with this approach or who will speak up for us if something goes wrong.

Patients don’t seem to know where to get their information, and they have been turning to increasingly bizarre sources. For the poorest, who have had so much trouble accessing care, I cannot blame them for not knowing whom to trust. I post what I know on Twitter and Facebook, but I know I’m no match for cynical social media algorithms.

Testing was still not available at my clinic the first week of March, and it remains largely unavailable throughout much of the country. We have lost weeks of opportunity to contain this. Luckily, on March 4, the University of Washington was finally allowed to use their homegrown test and bypass the limited supply from the CDC. But our capacity at UW is still limited, and the test remained unavailable to the majority of those potentially showing symptoms until March 9.

I am used to being less worried than my patients. I am used to reassuring them. But over the first week of March, I had an eerie sense that my alarm far outstripped theirs. I got relatively few questions about coronavirus, even as the number of cases continued to rise. It wasn’t until the end of the week that I noticed a few were truly fearful. Patients started stealing the gloves and the hand sanitizer, and we had to zealously guard them. My hands are raw from washing.

Throughout this time, I have been grateful for a centralized drive with clear protocols. I am grateful for clear messages at the beginning and end of the day from our CEO. I hope that other clinics model this and have daily in-person meetings, because too much cannot be conveyed in an email when the situation changes hourly.

But our health system nationally was already stretched thin before, and providers have sacrificed a lot, especially in the most critical settings, to provide decent patient care. Now we are asked to risk our health and safety, and our family’s, and I worry about the erosion of trust and work conditions for those on the front lines. I also worry our patients won’t believe us when we have allowed the costs of care to continue to rise and ruin their lives. I worry about the millions of people without doctors to call because they have no insurance, and because so many primary care physicians have left unsustainable jobs.

I am grateful that few of my colleagues have been sick and that those that were called out. I am grateful for the new nurse practitioners in our clinic who took the lion’s share of possibly affected patients and triaged hundreds of phone calls, creating note and message templates that we all use. I am grateful that my clinic manager insisted on doing a drill with all the staff members.

I am grateful that we were reminded that we are a team and that if the call center and cleaning crews and front desk are excluded, then our protocols are useless. I am grateful that our registered nurses quickly shifted to triage. I am grateful that I have testing available.

This week, for the first time since I started working, multiple patients asked how I am doing and expressed their thanks. I am most grateful for them.

I can’t tell you what to do or what is going to happen, but I can tell you that you need to prepare now. You need to run drills and catch the holes in your plans before the pandemic reaches you. You need to be creative and honest about the flaws in your organization that this pandemic will inevitably expose. You need to meet with your team every day and remember that we are all going to be stretched even thinner than before.

Most of us will get through this, but many of us won’t. And for those who do, we need to be honest about our successes and failures. We need to build a system that can do better next time. Because this is not the last pandemic we will face.
 

Dr. Elisabeth Poorman is a general internist at a University of Washington neighborhood clinic in Kent. She completed her residency at Cambridge (Mass.) Health Alliance and specializes in addiction medicine. She also serves on the editorial advisory board of Internal Medicine News.

Khadija Hafidh, MD, was already booked on a 14-hour, direct flight from Dubai to Los Angeles, when the American College of Physicians (ACP) announced it was canceling its internal medicine meeting scheduled for April.

Canceling her hotel reservation was not a problem, and she was assured a refund for the conference fee, but her airline ticket was another matter, said Dr. Hafidh, an internist and diabetologist with the Dubai Health Authority.

“The airline I booked my ticket with is willing to waive the change fees, but will deduct a cancellation fee if I choose not to take the trip,” Dr. Hafidh said in an interview. “The cancellation fees is $300. A bit steep I must admit.”

Dr. Hafidh now faces a dilemma: Lose the $300 and cancel, or change her flight dates to June for the American Diabetes Association meeting in Chicago.

“But then again, we aren’t sure if that meeting will take place,” Dr. Hafidh said. “A few weeks ago I thought this whole thing was just a storm in a tea cup. However when it was declared a pandemic yesterday, it brought about another dimension.”

More than 25 medical meetings and conferences across the globe have been canceled or postponed because of COVID-19 concerns. The sudden cancellations have caused reservation woes and travel headaches for thousands of physicians who planned to attend the meetings. Some societies are considering the idea of virtual conferences, while other associations have scrapped their meetings until next year.

For physicians facing a canceled conference, the most likely question is, what now? Read on for tips and suggestions.
 

Reservation refunds vary

Refunds on airfare because of conference cancellations differ, depending on the airline and where you were traveling. Some airlines, such as United Airlines, have waived all change fees for tickets issued March 3, 2020, through March 31, 2020, and passengers can change their dates for up to 12 months after the ticket was issued.

Full refunds often depend on whether your ticket was nonrefundable when purchased. Many airlines, such as Delta, are providing full refunds if the airline canceled your flight. JetBlue is waiving all change and cancellation fees for customers scheduled to travel March 10, 2020, through April 30, 2020.

Las Vegas–based dermatologist H.L. Greenberg, MD, was satisfied with the credit he received from Southwest Airlines after the American Academy of Dermatology (AAD) canceled its Denver meeting. He and his staff were looking forward to the gathering, but he noted that the meeting would likely have been limited, even if it had take place as scheduled.

“I am disappointed that I won’t be able to meet with colleagues and industry to explore what the latest advances and interests are in dermatology,” he said. “Because many academic institutions were forbidding their faculty from traveling, the content of the meeting was going to be severely diminished. It’s just a rough time for everyone.”

Meanwhile, Asa Radix, MD, PhD, a New York–based internist, received a full refund for his Amtrak ticket to Boston when the Conference on Retroviruses and Opportunistic Infections (CROI) scheduled for early March was converted to a virtual meeting. Dr. Radix, senior director of research and education at the Callen-Lorde Community Health Center in New York, left another meeting in Brazil early to get to the Boston conference, he said.

“I was packed, but really that was a minor inconvenience,” he said in an interview. “I appreciate that they prioritized health concerns and changed to a virtual meeting. I received full refunds, no issues whatsoever. [It was] really great since I had no travel insurance.”

Check with your individual airline or train line for information about ticket refunds and credits. Many airlines are currently making special accommodations because of COVID-19. If your flight was covered by trip insurance, also called travel assistance, you are generally protected against unforeseen financial losses such as cancellations. The U.S. Department of Transportation provides this general online resource about airline refunds.
 

Hotel refunds probable

Most meeting organizations who have made the decision to cancel or postpone a conference also have canceled block hotel reservations reserved for the meeting. Medical associations are not directly refunding the hotel costs, but the majority of hotels are refunding reservations with no questions asked. Physicians interviewed for this story all reported no trouble getting refunds for their hotel reservations. However, attendees who did not book a hotel in official housing blocks should contact the hotel directly to cancel.

What about registration fees?

In response to COVID-19 cancellations, most conference leaders are refunding registration fees in full for both attendees and exhibitors. The refund may not be automatic, some associations such as ACP and the American College of Obstetricians and Gynecologists state it may take up to 45 days for the funds to be credited, depending on the payment used.

If the conference you planned to attend was postponed, the registration fee may be assigned to the new meeting dates and the money may not be refunded. Registration fees for the Minimally Invasive Surgery Symposium, for example, delayed until an unconfirmed date, and for the European Association of Urology (EAU) meeting, postponed until July, will be automatically credited to the rescheduled meeting, according to the websites. If attendees cannot attend the rescheduled EAU meeting, the association will not provide a refund and the registration will not apply to the 2021 meeting, according to its website. However, the group is providing registrants with a free access code for the EAU20 Resource Centre, which contains websites of sessions and scientific content.

A number of physicians have expressed disappointment with the EAU’s postponement on social media. On Twitter, some doctors wrote that the rescheduled dates were bad timing, while others lamented the refund refusal.

The EAU said it regrets that some delegates will experience financial losses, but that the organization has already experienced a significant outlay that cannot be recovered including venue, logistics, travel, and accommodation costs.  

"We are doing what we can to absorb costs, but we need to be realistic about what is affordable; should the organization have to refund all or even most registrations, it would significantly jeopardize the viability of the organization," the EAU said in a statement.  "These are difficult times, not only for the EAU, but on a global scale. Where there are specific cases of hardship or very extenuating financial circumstances, we will be willing to review individual cases. So far, we believe that we have done what we can do to meet the conflicting demands presented by the postponement of the congress, but this is a situation which changes from day to day, and we need to continuously evaluate what might be the best course of action." * 

Contact your medical association directly for details on postponements.
 

What if I’m a presenter?

In an attempt to save the hard work and time that planners and presenters have invested into now-canceled meetings, some conferences are moving to a digital format. The Conference on Retroviruses and Opportunistic Infections (CROI) was the first to convert its in-person conference to a virtual meeting, held from March 8 to 11, 2020. At-home attendees logged onto CROI’s digital platform to hear plenaries, oral abstracts, themed discussion sessions, and symposia.

Dr. Radix was one of many CROI speakers who changed his presentation on HIV prevalence among transgender men to a virtual format.

“We were provided with detailed instructions from CROI about how to do this,” said Dr. Radix, who tweeted about the experience. “For my presentation, I used the video option in PowerPoint; it seemed the most straightforward and didn’t require buying additional software. It was fairly easy to follow the instructions to create the video but it was disappointing to present to an empty room.”

Matthew Spinelli, MD, an HIV researcher with the University of California, San Francisco, who also presented virtually, said it was remarkable that CROI leaders were able to put together the virtual program in such a short time. He delivered his presentation on the accuracy of a real-time urine tenofovir test using PowerPoint and a podcast microphone.

“It seemed to work pretty well,” he said in an interview. “It’s not the same as being there in person, there’s a lot of networking and chance conversations that happen when you’re all in the same place, but it was the right decision to cancel. If I have to be at home or at work doing social distancing, this was the best possible way of doing it.”

Following in CROI’s footsteps, the National Kidney Foundation’s spring conference has moved to a live virtual conference. The 2020 Healthcare Information and Management Systems Society (HIMSS) global health conference also will move to a digital format. Other societies are considering similar virtual options. Check with your meeting website for more details on digital options and attendee access.

[email protected]

*The article was updated on 03/16/2020.

Khadija Hafidh, MD, was already booked on a 14-hour, direct flight from Dubai to Los Angeles, when the American College of Physicians (ACP) announced it was canceling its internal medicine meeting scheduled for April.

Canceling her hotel reservation was not a problem, and she was assured a refund for the conference fee, but her airline ticket was another matter, said Dr. Hafidh, an internist and diabetologist with the Dubai Health Authority.

“The airline I booked my ticket with is willing to waive the change fees, but will deduct a cancellation fee if I choose not to take the trip,” Dr. Hafidh said in an interview. “The cancellation fees is $300. A bit steep I must admit.”

Dr. Hafidh now faces a dilemma: Lose the $300 and cancel, or change her flight dates to June for the American Diabetes Association meeting in Chicago.

“But then again, we aren’t sure if that meeting will take place,” Dr. Hafidh said. “A few weeks ago I thought this whole thing was just a storm in a tea cup. However when it was declared a pandemic yesterday, it brought about another dimension.”

More than 25 medical meetings and conferences across the globe have been canceled or postponed because of COVID-19 concerns. The sudden cancellations have caused reservation woes and travel headaches for thousands of physicians who planned to attend the meetings. Some societies are considering the idea of virtual conferences, while other associations have scrapped their meetings until next year.

For physicians facing a canceled conference, the most likely question is, what now? Read on for tips and suggestions.
 

Reservation refunds vary

Refunds on airfare because of conference cancellations differ, depending on the airline and where you were traveling. Some airlines, such as United Airlines, have waived all change fees for tickets issued March 3, 2020, through March 31, 2020, and passengers can change their dates for up to 12 months after the ticket was issued.

Full refunds often depend on whether your ticket was nonrefundable when purchased. Many airlines, such as Delta, are providing full refunds if the airline canceled your flight. JetBlue is waiving all change and cancellation fees for customers scheduled to travel March 10, 2020, through April 30, 2020.

Las Vegas–based dermatologist H.L. Greenberg, MD, was satisfied with the credit he received from Southwest Airlines after the American Academy of Dermatology (AAD) canceled its Denver meeting. He and his staff were looking forward to the gathering, but he noted that the meeting would likely have been limited, even if it had take place as scheduled.

“I am disappointed that I won’t be able to meet with colleagues and industry to explore what the latest advances and interests are in dermatology,” he said. “Because many academic institutions were forbidding their faculty from traveling, the content of the meeting was going to be severely diminished. It’s just a rough time for everyone.”

Meanwhile, Asa Radix, MD, PhD, a New York–based internist, received a full refund for his Amtrak ticket to Boston when the Conference on Retroviruses and Opportunistic Infections (CROI) scheduled for early March was converted to a virtual meeting. Dr. Radix, senior director of research and education at the Callen-Lorde Community Health Center in New York, left another meeting in Brazil early to get to the Boston conference, he said.

“I was packed, but really that was a minor inconvenience,” he said in an interview. “I appreciate that they prioritized health concerns and changed to a virtual meeting. I received full refunds, no issues whatsoever. [It was] really great since I had no travel insurance.”

Check with your individual airline or train line for information about ticket refunds and credits. Many airlines are currently making special accommodations because of COVID-19. If your flight was covered by trip insurance, also called travel assistance, you are generally protected against unforeseen financial losses such as cancellations. The U.S. Department of Transportation provides this general online resource about airline refunds.
 

Hotel refunds probable

Most meeting organizations who have made the decision to cancel or postpone a conference also have canceled block hotel reservations reserved for the meeting. Medical associations are not directly refunding the hotel costs, but the majority of hotels are refunding reservations with no questions asked. Physicians interviewed for this story all reported no trouble getting refunds for their hotel reservations. However, attendees who did not book a hotel in official housing blocks should contact the hotel directly to cancel.

What about registration fees?

In response to COVID-19 cancellations, most conference leaders are refunding registration fees in full for both attendees and exhibitors. The refund may not be automatic, some associations such as ACP and the American College of Obstetricians and Gynecologists state it may take up to 45 days for the funds to be credited, depending on the payment used.

If the conference you planned to attend was postponed, the registration fee may be assigned to the new meeting dates and the money may not be refunded. Registration fees for the Minimally Invasive Surgery Symposium, for example, delayed until an unconfirmed date, and for the European Association of Urology (EAU) meeting, postponed until July, will be automatically credited to the rescheduled meeting, according to the websites. If attendees cannot attend the rescheduled EAU meeting, the association will not provide a refund and the registration will not apply to the 2021 meeting, according to its website. However, the group is providing registrants with a free access code for the EAU20 Resource Centre, which contains websites of sessions and scientific content.

A number of physicians have expressed disappointment with the EAU’s postponement on social media. On Twitter, some doctors wrote that the rescheduled dates were bad timing, while others lamented the refund refusal.

The EAU said it regrets that some delegates will experience financial losses, but that the organization has already experienced a significant outlay that cannot be recovered including venue, logistics, travel, and accommodation costs.  

"We are doing what we can to absorb costs, but we need to be realistic about what is affordable; should the organization have to refund all or even most registrations, it would significantly jeopardize the viability of the organization," the EAU said in a statement.  "These are difficult times, not only for the EAU, but on a global scale. Where there are specific cases of hardship or very extenuating financial circumstances, we will be willing to review individual cases. So far, we believe that we have done what we can do to meet the conflicting demands presented by the postponement of the congress, but this is a situation which changes from day to day, and we need to continuously evaluate what might be the best course of action." * 

Contact your medical association directly for details on postponements.
 

What if I’m a presenter?

In an attempt to save the hard work and time that planners and presenters have invested into now-canceled meetings, some conferences are moving to a digital format. The Conference on Retroviruses and Opportunistic Infections (CROI) was the first to convert its in-person conference to a virtual meeting, held from March 8 to 11, 2020. At-home attendees logged onto CROI’s digital platform to hear plenaries, oral abstracts, themed discussion sessions, and symposia.

Dr. Radix was one of many CROI speakers who changed his presentation on HIV prevalence among transgender men to a virtual format.

“We were provided with detailed instructions from CROI about how to do this,” said Dr. Radix, who tweeted about the experience. “For my presentation, I used the video option in PowerPoint; it seemed the most straightforward and didn’t require buying additional software. It was fairly easy to follow the instructions to create the video but it was disappointing to present to an empty room.”

Matthew Spinelli, MD, an HIV researcher with the University of California, San Francisco, who also presented virtually, said it was remarkable that CROI leaders were able to put together the virtual program in such a short time. He delivered his presentation on the accuracy of a real-time urine tenofovir test using PowerPoint and a podcast microphone.

“It seemed to work pretty well,” he said in an interview. “It’s not the same as being there in person, there’s a lot of networking and chance conversations that happen when you’re all in the same place, but it was the right decision to cancel. If I have to be at home or at work doing social distancing, this was the best possible way of doing it.”

Following in CROI’s footsteps, the National Kidney Foundation’s spring conference has moved to a live virtual conference. The 2020 Healthcare Information and Management Systems Society (HIMSS) global health conference also will move to a digital format. Other societies are considering similar virtual options. Check with your meeting website for more details on digital options and attendee access.

[email protected]

*The article was updated on 03/16/2020.

Khadija Hafidh, MD, was already booked on a 14-hour, direct flight from Dubai to Los Angeles, when the American College of Physicians (ACP) announced it was canceling its internal medicine meeting scheduled for April.

Canceling her hotel reservation was not a problem, and she was assured a refund for the conference fee, but her airline ticket was another matter, said Dr. Hafidh, an internist and diabetologist with the Dubai Health Authority.

“The airline I booked my ticket with is willing to waive the change fees, but will deduct a cancellation fee if I choose not to take the trip,” Dr. Hafidh said in an interview. “The cancellation fees is $300. A bit steep I must admit.”

Dr. Hafidh now faces a dilemma: Lose the $300 and cancel, or change her flight dates to June for the American Diabetes Association meeting in Chicago.

“But then again, we aren’t sure if that meeting will take place,” Dr. Hafidh said. “A few weeks ago I thought this whole thing was just a storm in a tea cup. However when it was declared a pandemic yesterday, it brought about another dimension.”

More than 25 medical meetings and conferences across the globe have been canceled or postponed because of COVID-19 concerns. The sudden cancellations have caused reservation woes and travel headaches for thousands of physicians who planned to attend the meetings. Some societies are considering the idea of virtual conferences, while other associations have scrapped their meetings until next year.

For physicians facing a canceled conference, the most likely question is, what now? Read on for tips and suggestions.
 

Reservation refunds vary

Refunds on airfare because of conference cancellations differ, depending on the airline and where you were traveling. Some airlines, such as United Airlines, have waived all change fees for tickets issued March 3, 2020, through March 31, 2020, and passengers can change their dates for up to 12 months after the ticket was issued.

Full refunds often depend on whether your ticket was nonrefundable when purchased. Many airlines, such as Delta, are providing full refunds if the airline canceled your flight. JetBlue is waiving all change and cancellation fees for customers scheduled to travel March 10, 2020, through April 30, 2020.

Las Vegas–based dermatologist H.L. Greenberg, MD, was satisfied with the credit he received from Southwest Airlines after the American Academy of Dermatology (AAD) canceled its Denver meeting. He and his staff were looking forward to the gathering, but he noted that the meeting would likely have been limited, even if it had take place as scheduled.

“I am disappointed that I won’t be able to meet with colleagues and industry to explore what the latest advances and interests are in dermatology,” he said. “Because many academic institutions were forbidding their faculty from traveling, the content of the meeting was going to be severely diminished. It’s just a rough time for everyone.”

Meanwhile, Asa Radix, MD, PhD, a New York–based internist, received a full refund for his Amtrak ticket to Boston when the Conference on Retroviruses and Opportunistic Infections (CROI) scheduled for early March was converted to a virtual meeting. Dr. Radix, senior director of research and education at the Callen-Lorde Community Health Center in New York, left another meeting in Brazil early to get to the Boston conference, he said.

“I was packed, but really that was a minor inconvenience,” he said in an interview. “I appreciate that they prioritized health concerns and changed to a virtual meeting. I received full refunds, no issues whatsoever. [It was] really great since I had no travel insurance.”

Check with your individual airline or train line for information about ticket refunds and credits. Many airlines are currently making special accommodations because of COVID-19. If your flight was covered by trip insurance, also called travel assistance, you are generally protected against unforeseen financial losses such as cancellations. The U.S. Department of Transportation provides this general online resource about airline refunds.
 

Hotel refunds probable

Most meeting organizations who have made the decision to cancel or postpone a conference also have canceled block hotel reservations reserved for the meeting. Medical associations are not directly refunding the hotel costs, but the majority of hotels are refunding reservations with no questions asked. Physicians interviewed for this story all reported no trouble getting refunds for their hotel reservations. However, attendees who did not book a hotel in official housing blocks should contact the hotel directly to cancel.

What about registration fees?

In response to COVID-19 cancellations, most conference leaders are refunding registration fees in full for both attendees and exhibitors. The refund may not be automatic, some associations such as ACP and the American College of Obstetricians and Gynecologists state it may take up to 45 days for the funds to be credited, depending on the payment used.

If the conference you planned to attend was postponed, the registration fee may be assigned to the new meeting dates and the money may not be refunded. Registration fees for the Minimally Invasive Surgery Symposium, for example, delayed until an unconfirmed date, and for the European Association of Urology (EAU) meeting, postponed until July, will be automatically credited to the rescheduled meeting, according to the websites. If attendees cannot attend the rescheduled EAU meeting, the association will not provide a refund and the registration will not apply to the 2021 meeting, according to its website. However, the group is providing registrants with a free access code for the EAU20 Resource Centre, which contains websites of sessions and scientific content.

A number of physicians have expressed disappointment with the EAU’s postponement on social media. On Twitter, some doctors wrote that the rescheduled dates were bad timing, while others lamented the refund refusal.

The EAU said it regrets that some delegates will experience financial losses, but that the organization has already experienced a significant outlay that cannot be recovered including venue, logistics, travel, and accommodation costs.  

"We are doing what we can to absorb costs, but we need to be realistic about what is affordable; should the organization have to refund all or even most registrations, it would significantly jeopardize the viability of the organization," the EAU said in a statement.  "These are difficult times, not only for the EAU, but on a global scale. Where there are specific cases of hardship or very extenuating financial circumstances, we will be willing to review individual cases. So far, we believe that we have done what we can do to meet the conflicting demands presented by the postponement of the congress, but this is a situation which changes from day to day, and we need to continuously evaluate what might be the best course of action." * 

Contact your medical association directly for details on postponements.
 

What if I’m a presenter?

In an attempt to save the hard work and time that planners and presenters have invested into now-canceled meetings, some conferences are moving to a digital format. The Conference on Retroviruses and Opportunistic Infections (CROI) was the first to convert its in-person conference to a virtual meeting, held from March 8 to 11, 2020. At-home attendees logged onto CROI’s digital platform to hear plenaries, oral abstracts, themed discussion sessions, and symposia.

Dr. Radix was one of many CROI speakers who changed his presentation on HIV prevalence among transgender men to a virtual format.

“We were provided with detailed instructions from CROI about how to do this,” said Dr. Radix, who tweeted about the experience. “For my presentation, I used the video option in PowerPoint; it seemed the most straightforward and didn’t require buying additional software. It was fairly easy to follow the instructions to create the video but it was disappointing to present to an empty room.”

Matthew Spinelli, MD, an HIV researcher with the University of California, San Francisco, who also presented virtually, said it was remarkable that CROI leaders were able to put together the virtual program in such a short time. He delivered his presentation on the accuracy of a real-time urine tenofovir test using PowerPoint and a podcast microphone.

“It seemed to work pretty well,” he said in an interview. “It’s not the same as being there in person, there’s a lot of networking and chance conversations that happen when you’re all in the same place, but it was the right decision to cancel. If I have to be at home or at work doing social distancing, this was the best possible way of doing it.”

Following in CROI’s footsteps, the National Kidney Foundation’s spring conference has moved to a live virtual conference. The 2020 Healthcare Information and Management Systems Society (HIMSS) global health conference also will move to a digital format. Other societies are considering similar virtual options. Check with your meeting website for more details on digital options and attendee access.

[email protected]

*The article was updated on 03/16/2020.

The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.

“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also sponsored a public workshop on March 9 to discuss competition for biologics.

The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.

Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.

“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”

Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.

The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.

[email protected]

The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.

“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also sponsored a public workshop on March 9 to discuss competition for biologics.

The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.

Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.

“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”

Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.

The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.

[email protected]

The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.

“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also sponsored a public workshop on March 9 to discuss competition for biologics.

The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.

Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.

“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”

Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.

The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.

[email protected]