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Value-based care stunted from delayed Stark and anti-kickback statute reform
Anti-kickback statutes (AKSs) were originally enacted in 1931 to stop Great Depression–era employers from circumventing wage provisions in federal contracts. Since its enactment, AKSs’ main focus has changed and is currently aimed at the health care industry. In addition to AKSs, Stark laws were enacted over 30 years ago to address physician self-referral of Medicare patients. Both laws comprise the government’s main tools for fighting fraud, waste, and abuse.
However, AKSs and Stark laws have not been updated to keep pace with changes in how medical practices do business and care for patients.
Over the years, additional interpretation and clarification has been issued by the Department of Health and Human Services (DHHS) and the Office of Inspector General (OIG). In DHHSs’ June 1, 2012 Advisory Opinion No. 12-06 there is guidance regarding legality of anesthesia services providers’ contract with physician-owned professional corporations or limited liability companies to provide anesthesia services. Specifically, it focused on the “company model” where owners of an ambulatory surgery center (ASC) create a separate company for anesthesia services which directly contracts with anesthesia providers and charges for the anesthesia services while the ASC charges for facility fees. Anyone with specific questions may request an advisory opinion from the OIG about the application of OIG’s fraud and abuse authorities and existing or proposed business arrangements. An OIG advisory opinion is legally binding on the requesting party and DHHS, but not on any other governmental department or agency. While advisory opinions are specific to the entity that requested it and specifically states, “This opinion may not be relied on by any persons other than [name redacted], the requestor of this opinion....” It captured the attention of the medical community. The AGA has argued that this opinion should not be interpreted to mean that all company model frameworks necessarily violate the AKSs and the OIG’s Advisor Opinions FAQ states no person or entity can rely on an advisory opinion issued to someone else. However, Advisory Opinion No. 12-06 has been cited in AKS investigations ever since.
When Congress passed the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015, it changed how physicians would be paid under Medicare and sought to transition physicians to a more value-based payment system. Physicians were incentivized to develop physician-driven payment models to improve efficiency and patient outcomes. However, existing Stark self-referral laws prohibit physicians from referring patients to an entity in which they have a financial interest. As a result, physician practices are unable to participate in many advanced alternative payment models. Stark laws, which have not been updated since their enactment 30 years ago, pose barriers to care coordination since they prohibit payment arrangements that consider volume or value of referrals or other business generated by the parties. These prohibitions stifle innovations in delivering care by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.
Congress recognized that the Stark law was a barrier to new health care delivery models. Congress, therefore, authorized the HHS Secretary to waive Stark self-referral and anti-kickback laws for accountable care organizations (ACOs). This waiver was not extended to physician-driven alternative payment models (APMs), that also need these exceptions to drive innovation in health care and to implement MACRA law as Congress intended.
AGA and the physician community have long sought to update Stark self-referral and AKSs. Last year, CMS proposed exceptions directed at value-based arrangements that would have allowed providers to participate in value-based arrangements while still protecting the Medicare program from potential abuses. Many of the changes that CMS proposed would have allowed physician practices to engage in value-based arrangements that would improve patient care and AGA provided comments on both the Stark and AKS proposed rules. However, CMS has not yet issued the final rules and has indicated that they will not issue a final rule on Stark which a lost opportunity to improve health care delivery.
On the legislative front, AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements. The legislation would allow CMS to waive the Stark laws for physicians seeking to develop and operate APMs similar to what Congress allowed for ACOs. The legislation would allow innovative payment models developed by gastroenterologists to be implemented in the Medicare program. Unfortunately, this legislation has received little traction in Congress.
Until meaningful regulatory and legislative reform updating both Stark and AKS occur, innovative payment models must wait and gastroenterologists and other providers will remain vulnerable to these outdated regulations. You can help us advance these issues by sharing how they impact your practice. Tell us what types of value-based arrangements you would participate in and how would they improve patient care and efficacy at [email protected].
Dr. Losurdo is the AGA’s Alternate Advisor to the American Medical Association’s CPT Editorial Panel, a member of the AGA Practice Management and Economics Committee’s Coverage and Reimbursement Subcommittee and is a partner with Elgin Gastro Endoscopy, who owns and ASC, and Managing Partner and Medical Director of Illinois Gastroenterology Group/GI Alliance, Elgin, Ill.
This story was updated on 12/11/2020.
Anti-kickback statutes (AKSs) were originally enacted in 1931 to stop Great Depression–era employers from circumventing wage provisions in federal contracts. Since its enactment, AKSs’ main focus has changed and is currently aimed at the health care industry. In addition to AKSs, Stark laws were enacted over 30 years ago to address physician self-referral of Medicare patients. Both laws comprise the government’s main tools for fighting fraud, waste, and abuse.
However, AKSs and Stark laws have not been updated to keep pace with changes in how medical practices do business and care for patients.
Over the years, additional interpretation and clarification has been issued by the Department of Health and Human Services (DHHS) and the Office of Inspector General (OIG). In DHHSs’ June 1, 2012 Advisory Opinion No. 12-06 there is guidance regarding legality of anesthesia services providers’ contract with physician-owned professional corporations or limited liability companies to provide anesthesia services. Specifically, it focused on the “company model” where owners of an ambulatory surgery center (ASC) create a separate company for anesthesia services which directly contracts with anesthesia providers and charges for the anesthesia services while the ASC charges for facility fees. Anyone with specific questions may request an advisory opinion from the OIG about the application of OIG’s fraud and abuse authorities and existing or proposed business arrangements. An OIG advisory opinion is legally binding on the requesting party and DHHS, but not on any other governmental department or agency. While advisory opinions are specific to the entity that requested it and specifically states, “This opinion may not be relied on by any persons other than [name redacted], the requestor of this opinion....” It captured the attention of the medical community. The AGA has argued that this opinion should not be interpreted to mean that all company model frameworks necessarily violate the AKSs and the OIG’s Advisor Opinions FAQ states no person or entity can rely on an advisory opinion issued to someone else. However, Advisory Opinion No. 12-06 has been cited in AKS investigations ever since.
When Congress passed the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015, it changed how physicians would be paid under Medicare and sought to transition physicians to a more value-based payment system. Physicians were incentivized to develop physician-driven payment models to improve efficiency and patient outcomes. However, existing Stark self-referral laws prohibit physicians from referring patients to an entity in which they have a financial interest. As a result, physician practices are unable to participate in many advanced alternative payment models. Stark laws, which have not been updated since their enactment 30 years ago, pose barriers to care coordination since they prohibit payment arrangements that consider volume or value of referrals or other business generated by the parties. These prohibitions stifle innovations in delivering care by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.
Congress recognized that the Stark law was a barrier to new health care delivery models. Congress, therefore, authorized the HHS Secretary to waive Stark self-referral and anti-kickback laws for accountable care organizations (ACOs). This waiver was not extended to physician-driven alternative payment models (APMs), that also need these exceptions to drive innovation in health care and to implement MACRA law as Congress intended.
AGA and the physician community have long sought to update Stark self-referral and AKSs. Last year, CMS proposed exceptions directed at value-based arrangements that would have allowed providers to participate in value-based arrangements while still protecting the Medicare program from potential abuses. Many of the changes that CMS proposed would have allowed physician practices to engage in value-based arrangements that would improve patient care and AGA provided comments on both the Stark and AKS proposed rules. However, CMS has not yet issued the final rules and has indicated that they will not issue a final rule on Stark which a lost opportunity to improve health care delivery.
On the legislative front, AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements. The legislation would allow CMS to waive the Stark laws for physicians seeking to develop and operate APMs similar to what Congress allowed for ACOs. The legislation would allow innovative payment models developed by gastroenterologists to be implemented in the Medicare program. Unfortunately, this legislation has received little traction in Congress.
Until meaningful regulatory and legislative reform updating both Stark and AKS occur, innovative payment models must wait and gastroenterologists and other providers will remain vulnerable to these outdated regulations. You can help us advance these issues by sharing how they impact your practice. Tell us what types of value-based arrangements you would participate in and how would they improve patient care and efficacy at [email protected].
Dr. Losurdo is the AGA’s Alternate Advisor to the American Medical Association’s CPT Editorial Panel, a member of the AGA Practice Management and Economics Committee’s Coverage and Reimbursement Subcommittee and is a partner with Elgin Gastro Endoscopy, who owns and ASC, and Managing Partner and Medical Director of Illinois Gastroenterology Group/GI Alliance, Elgin, Ill.
This story was updated on 12/11/2020.
Anti-kickback statutes (AKSs) were originally enacted in 1931 to stop Great Depression–era employers from circumventing wage provisions in federal contracts. Since its enactment, AKSs’ main focus has changed and is currently aimed at the health care industry. In addition to AKSs, Stark laws were enacted over 30 years ago to address physician self-referral of Medicare patients. Both laws comprise the government’s main tools for fighting fraud, waste, and abuse.
However, AKSs and Stark laws have not been updated to keep pace with changes in how medical practices do business and care for patients.
Over the years, additional interpretation and clarification has been issued by the Department of Health and Human Services (DHHS) and the Office of Inspector General (OIG). In DHHSs’ June 1, 2012 Advisory Opinion No. 12-06 there is guidance regarding legality of anesthesia services providers’ contract with physician-owned professional corporations or limited liability companies to provide anesthesia services. Specifically, it focused on the “company model” where owners of an ambulatory surgery center (ASC) create a separate company for anesthesia services which directly contracts with anesthesia providers and charges for the anesthesia services while the ASC charges for facility fees. Anyone with specific questions may request an advisory opinion from the OIG about the application of OIG’s fraud and abuse authorities and existing or proposed business arrangements. An OIG advisory opinion is legally binding on the requesting party and DHHS, but not on any other governmental department or agency. While advisory opinions are specific to the entity that requested it and specifically states, “This opinion may not be relied on by any persons other than [name redacted], the requestor of this opinion....” It captured the attention of the medical community. The AGA has argued that this opinion should not be interpreted to mean that all company model frameworks necessarily violate the AKSs and the OIG’s Advisor Opinions FAQ states no person or entity can rely on an advisory opinion issued to someone else. However, Advisory Opinion No. 12-06 has been cited in AKS investigations ever since.
When Congress passed the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015, it changed how physicians would be paid under Medicare and sought to transition physicians to a more value-based payment system. Physicians were incentivized to develop physician-driven payment models to improve efficiency and patient outcomes. However, existing Stark self-referral laws prohibit physicians from referring patients to an entity in which they have a financial interest. As a result, physician practices are unable to participate in many advanced alternative payment models. Stark laws, which have not been updated since their enactment 30 years ago, pose barriers to care coordination since they prohibit payment arrangements that consider volume or value of referrals or other business generated by the parties. These prohibitions stifle innovations in delivering care by inhibiting practices from incentivizing their physicians to deliver patient care more efficiently, because the practices cannot use resources from designated health services in rewarding or penalizing adherence to new clinical care pathways.
Congress recognized that the Stark law was a barrier to new health care delivery models. Congress, therefore, authorized the HHS Secretary to waive Stark self-referral and anti-kickback laws for accountable care organizations (ACOs). This waiver was not extended to physician-driven alternative payment models (APMs), that also need these exceptions to drive innovation in health care and to implement MACRA law as Congress intended.
AGA and the physician community have long sought to update Stark self-referral and AKSs. Last year, CMS proposed exceptions directed at value-based arrangements that would have allowed providers to participate in value-based arrangements while still protecting the Medicare program from potential abuses. Many of the changes that CMS proposed would have allowed physician practices to engage in value-based arrangements that would improve patient care and AGA provided comments on both the Stark and AKS proposed rules. However, CMS has not yet issued the final rules and has indicated that they will not issue a final rule on Stark which a lost opportunity to improve health care delivery.
On the legislative front, AGA supports S. 2051/H.R. 4206, the Medicare Care Coordination Improvement Act, which would provide CMS with the regulatory authority to create exceptions under the Stark law for APMs and to remove barriers in the current law to the development and operation of such arrangements. The legislation would allow CMS to waive the Stark laws for physicians seeking to develop and operate APMs similar to what Congress allowed for ACOs. The legislation would allow innovative payment models developed by gastroenterologists to be implemented in the Medicare program. Unfortunately, this legislation has received little traction in Congress.
Until meaningful regulatory and legislative reform updating both Stark and AKS occur, innovative payment models must wait and gastroenterologists and other providers will remain vulnerable to these outdated regulations. You can help us advance these issues by sharing how they impact your practice. Tell us what types of value-based arrangements you would participate in and how would they improve patient care and efficacy at [email protected].
Dr. Losurdo is the AGA’s Alternate Advisor to the American Medical Association’s CPT Editorial Panel, a member of the AGA Practice Management and Economics Committee’s Coverage and Reimbursement Subcommittee and is a partner with Elgin Gastro Endoscopy, who owns and ASC, and Managing Partner and Medical Director of Illinois Gastroenterology Group/GI Alliance, Elgin, Ill.
This story was updated on 12/11/2020.
Top AGA Community patient cases
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The upgraded networking platform now features a newsfeed for difficult patient scenarios and regularly scheduled Roundtable discussions with experts in the field.
In case you missed it, here are some clinical discussions and Roundtables in the newsfeed this month:
Practice update: Small intestinal bacteria overgrowth (SIBO) (https://community.gastro.org/posts/22838)
Case: Polypectomy with low neutrophils (https://community.gastro.org/posts/22844)
Case: Esophagus adenocarcinoma after sleeve gastrectomy (https://community.gastro.org/posts/22868)
Case: Restarting infliximab after shingles – when is it safe? (https://community.gastro.org/posts/22890)
Case: Flatulence in Colorado (https://community.gastro.org/posts/22901)
Case: Serrated epithelial change (SEC) in IBD (https://community.gastro.org/posts/22948)
Case: Multiloculated pancreatic cyst (https://community.gastro.org/posts/22935)
View all upcoming Roundtables in the community at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The upgraded networking platform now features a newsfeed for difficult patient scenarios and regularly scheduled Roundtable discussions with experts in the field.
In case you missed it, here are some clinical discussions and Roundtables in the newsfeed this month:
Practice update: Small intestinal bacteria overgrowth (SIBO) (https://community.gastro.org/posts/22838)
Case: Polypectomy with low neutrophils (https://community.gastro.org/posts/22844)
Case: Esophagus adenocarcinoma after sleeve gastrectomy (https://community.gastro.org/posts/22868)
Case: Restarting infliximab after shingles – when is it safe? (https://community.gastro.org/posts/22890)
Case: Flatulence in Colorado (https://community.gastro.org/posts/22901)
Case: Serrated epithelial change (SEC) in IBD (https://community.gastro.org/posts/22948)
Case: Multiloculated pancreatic cyst (https://community.gastro.org/posts/22935)
View all upcoming Roundtables in the community at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The upgraded networking platform now features a newsfeed for difficult patient scenarios and regularly scheduled Roundtable discussions with experts in the field.
In case you missed it, here are some clinical discussions and Roundtables in the newsfeed this month:
Practice update: Small intestinal bacteria overgrowth (SIBO) (https://community.gastro.org/posts/22838)
Case: Polypectomy with low neutrophils (https://community.gastro.org/posts/22844)
Case: Esophagus adenocarcinoma after sleeve gastrectomy (https://community.gastro.org/posts/22868)
Case: Restarting infliximab after shingles – when is it safe? (https://community.gastro.org/posts/22890)
Case: Flatulence in Colorado (https://community.gastro.org/posts/22901)
Case: Serrated epithelial change (SEC) in IBD (https://community.gastro.org/posts/22948)
Case: Multiloculated pancreatic cyst (https://community.gastro.org/posts/22935)
View all upcoming Roundtables in the community at https://community.gastro.org/discussions.
CGH releases its first GI cancer-themed issue
Articles include guidance on cancer progression in Barrett’s esophagus patients, CRC surveillance, and HCC incidence and risk.
Clinical Gastroenterology and Hepatology (CGH) is proud to release its first themed issue on GI cancers. This “issue within an issue” includes a collection of articles, selected by editor-in-chief Dr. Fasiha Kanwal, that will provide you with practical research to help guide cancer prevention, surveillance and treatment decisions for your patients.
View the themed issue on CGH’s website. and access other curated collections on cghjournal.org.
How can we combat health disparities in GI?
Hear from Craig Munroe, MD, on why we all need to donate to AGA Giving Day, now through Dec. 3, in order to fund GI health disparities research.
“Health disparities exist and negatively impact patients every day across our country. Working to solve these inequities for the good of our patients and workforce is fundamental to our calling as physicians,” says Craig A. Munroe, MD, associate chief for clinical innovation, University of California, San Francisco, AGA Diversity Committee member, AGA Equity Project advisory board member. “Although we have made tremendous strides over the decades, there is still much more that needs to be done. Disparate systems of care and legacies of inequality continue to cause great harm.”
That is why AGA is bringing together the GI community to fund health disparity research with the goal of improving care for all patients. With contributions raised through AGA Giving Day campaign, the AGA Research Foundation will fund research projects that help us understand health disparities and create strategies for overcoming them.
“I’m donating to AGA Giving Day because I believe the work being done will have an immediate positive impact, and will continue to benefit future generations of patients, physicians, scientists, health providers, and trainees.”
Please join Dr. Munroe and your AGA colleagues in making a tax-deductible donation to the AGA Research Foundation to support AGA Giving Day today through Dec. 3. Contributors will be recognized as supporters of our fight to achieve equity and eradicate disparities in digestive diseases. www.Gastro.org/GivingDay
Articles include guidance on cancer progression in Barrett’s esophagus patients, CRC surveillance, and HCC incidence and risk.
Clinical Gastroenterology and Hepatology (CGH) is proud to release its first themed issue on GI cancers. This “issue within an issue” includes a collection of articles, selected by editor-in-chief Dr. Fasiha Kanwal, that will provide you with practical research to help guide cancer prevention, surveillance and treatment decisions for your patients.
View the themed issue on CGH’s website. and access other curated collections on cghjournal.org.
How can we combat health disparities in GI?
Hear from Craig Munroe, MD, on why we all need to donate to AGA Giving Day, now through Dec. 3, in order to fund GI health disparities research.
“Health disparities exist and negatively impact patients every day across our country. Working to solve these inequities for the good of our patients and workforce is fundamental to our calling as physicians,” says Craig A. Munroe, MD, associate chief for clinical innovation, University of California, San Francisco, AGA Diversity Committee member, AGA Equity Project advisory board member. “Although we have made tremendous strides over the decades, there is still much more that needs to be done. Disparate systems of care and legacies of inequality continue to cause great harm.”
That is why AGA is bringing together the GI community to fund health disparity research with the goal of improving care for all patients. With contributions raised through AGA Giving Day campaign, the AGA Research Foundation will fund research projects that help us understand health disparities and create strategies for overcoming them.
“I’m donating to AGA Giving Day because I believe the work being done will have an immediate positive impact, and will continue to benefit future generations of patients, physicians, scientists, health providers, and trainees.”
Please join Dr. Munroe and your AGA colleagues in making a tax-deductible donation to the AGA Research Foundation to support AGA Giving Day today through Dec. 3. Contributors will be recognized as supporters of our fight to achieve equity and eradicate disparities in digestive diseases. www.Gastro.org/GivingDay
Articles include guidance on cancer progression in Barrett’s esophagus patients, CRC surveillance, and HCC incidence and risk.
Clinical Gastroenterology and Hepatology (CGH) is proud to release its first themed issue on GI cancers. This “issue within an issue” includes a collection of articles, selected by editor-in-chief Dr. Fasiha Kanwal, that will provide you with practical research to help guide cancer prevention, surveillance and treatment decisions for your patients.
View the themed issue on CGH’s website. and access other curated collections on cghjournal.org.
How can we combat health disparities in GI?
Hear from Craig Munroe, MD, on why we all need to donate to AGA Giving Day, now through Dec. 3, in order to fund GI health disparities research.
“Health disparities exist and negatively impact patients every day across our country. Working to solve these inequities for the good of our patients and workforce is fundamental to our calling as physicians,” says Craig A. Munroe, MD, associate chief for clinical innovation, University of California, San Francisco, AGA Diversity Committee member, AGA Equity Project advisory board member. “Although we have made tremendous strides over the decades, there is still much more that needs to be done. Disparate systems of care and legacies of inequality continue to cause great harm.”
That is why AGA is bringing together the GI community to fund health disparity research with the goal of improving care for all patients. With contributions raised through AGA Giving Day campaign, the AGA Research Foundation will fund research projects that help us understand health disparities and create strategies for overcoming them.
“I’m donating to AGA Giving Day because I believe the work being done will have an immediate positive impact, and will continue to benefit future generations of patients, physicians, scientists, health providers, and trainees.”
Please join Dr. Munroe and your AGA colleagues in making a tax-deductible donation to the AGA Research Foundation to support AGA Giving Day today through Dec. 3. Contributors will be recognized as supporters of our fight to achieve equity and eradicate disparities in digestive diseases. www.Gastro.org/GivingDay
Congrats to these five AGA members
We’re proud to share the news of two AGA members elected to the prestigious National Academy of Medicine and three honored with the 2020 Sherman Prize.
Congratulations to AGA members Judy H. Cho, MD, and B. Mark Evers, MD, who were recently elected to the National Academy of Medicine.
Judy H. Cho, MD, professor of medicine at Icahn School of Medicine at Mount Sinai, New York, for “establishing that uncommon, loss-of-function variants in the microbial-sensing domain of NOD2 confer risk for Crohn’s disease, and identifying a loss-of-function allele in the IL-23 receptor that protects against Crohn’s disease and ulcerative colitis, leading to new, approved therapies.”
B. Mark Evers, MD, physician in chief of oncology service at University of Kentucky Healthcare, for “his expertise on intestinal hormones and hormonal arcades in oncogenesis. His seminal insights defined the role of gut hormones on normal physiology and metabolism, pioneering innovative understanding of neuroendocrine cell biology and the role of neurohormonal pathways in the development and progression of neuroendocrine tumors.”
Being selected to the Academy is one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.
In addition, the 2020 Sherman Prize was awarded to the following three AGA members:
David Rubin, MD, AGAF, chief, section of gastroenterology, hepatology and nutrition at University of Chicago Medicine, for his “renown in the IBD community as a brilliant clinician, creative researcher, tireless advocate, and trailblazing educator.”
Gary Wu, MD, professor of medicine at University of Pennsylvania, Perelman School of Medicine, for “pioneering the study of the gut microbiome in IBD, publishing seminal research on the relationship between diet and the microbiome — enabling multiple areas of research into dietary interventions for IBD.“
Jessica Allegretti, MD, MPH, director of clinical trials at Brigham and Women’s Hospital, as a “highly regarded expert in the field of fecal microbiota transplantation (FMT) and microbiome therapeutics, establishing the therapy as an effective treatment in IBD patients with recurrent C. difficile.”
Presented by the Bruce and Cynthia Sherman Charitable Foundation, the Sherman Prize is awarded to experts in the field of Crohn’s disease and ulcerative colitis who have exhibited their commitment to advancing inflammatory bowel disease care and have dedicated their careers to overcome these diseases.
We’re proud to share the news of two AGA members elected to the prestigious National Academy of Medicine and three honored with the 2020 Sherman Prize.
Congratulations to AGA members Judy H. Cho, MD, and B. Mark Evers, MD, who were recently elected to the National Academy of Medicine.
Judy H. Cho, MD, professor of medicine at Icahn School of Medicine at Mount Sinai, New York, for “establishing that uncommon, loss-of-function variants in the microbial-sensing domain of NOD2 confer risk for Crohn’s disease, and identifying a loss-of-function allele in the IL-23 receptor that protects against Crohn’s disease and ulcerative colitis, leading to new, approved therapies.”
B. Mark Evers, MD, physician in chief of oncology service at University of Kentucky Healthcare, for “his expertise on intestinal hormones and hormonal arcades in oncogenesis. His seminal insights defined the role of gut hormones on normal physiology and metabolism, pioneering innovative understanding of neuroendocrine cell biology and the role of neurohormonal pathways in the development and progression of neuroendocrine tumors.”
Being selected to the Academy is one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.
In addition, the 2020 Sherman Prize was awarded to the following three AGA members:
David Rubin, MD, AGAF, chief, section of gastroenterology, hepatology and nutrition at University of Chicago Medicine, for his “renown in the IBD community as a brilliant clinician, creative researcher, tireless advocate, and trailblazing educator.”
Gary Wu, MD, professor of medicine at University of Pennsylvania, Perelman School of Medicine, for “pioneering the study of the gut microbiome in IBD, publishing seminal research on the relationship between diet and the microbiome — enabling multiple areas of research into dietary interventions for IBD.“
Jessica Allegretti, MD, MPH, director of clinical trials at Brigham and Women’s Hospital, as a “highly regarded expert in the field of fecal microbiota transplantation (FMT) and microbiome therapeutics, establishing the therapy as an effective treatment in IBD patients with recurrent C. difficile.”
Presented by the Bruce and Cynthia Sherman Charitable Foundation, the Sherman Prize is awarded to experts in the field of Crohn’s disease and ulcerative colitis who have exhibited their commitment to advancing inflammatory bowel disease care and have dedicated their careers to overcome these diseases.
We’re proud to share the news of two AGA members elected to the prestigious National Academy of Medicine and three honored with the 2020 Sherman Prize.
Congratulations to AGA members Judy H. Cho, MD, and B. Mark Evers, MD, who were recently elected to the National Academy of Medicine.
Judy H. Cho, MD, professor of medicine at Icahn School of Medicine at Mount Sinai, New York, for “establishing that uncommon, loss-of-function variants in the microbial-sensing domain of NOD2 confer risk for Crohn’s disease, and identifying a loss-of-function allele in the IL-23 receptor that protects against Crohn’s disease and ulcerative colitis, leading to new, approved therapies.”
B. Mark Evers, MD, physician in chief of oncology service at University of Kentucky Healthcare, for “his expertise on intestinal hormones and hormonal arcades in oncogenesis. His seminal insights defined the role of gut hormones on normal physiology and metabolism, pioneering innovative understanding of neuroendocrine cell biology and the role of neurohormonal pathways in the development and progression of neuroendocrine tumors.”
Being selected to the Academy is one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.
In addition, the 2020 Sherman Prize was awarded to the following three AGA members:
David Rubin, MD, AGAF, chief, section of gastroenterology, hepatology and nutrition at University of Chicago Medicine, for his “renown in the IBD community as a brilliant clinician, creative researcher, tireless advocate, and trailblazing educator.”
Gary Wu, MD, professor of medicine at University of Pennsylvania, Perelman School of Medicine, for “pioneering the study of the gut microbiome in IBD, publishing seminal research on the relationship between diet and the microbiome — enabling multiple areas of research into dietary interventions for IBD.“
Jessica Allegretti, MD, MPH, director of clinical trials at Brigham and Women’s Hospital, as a “highly regarded expert in the field of fecal microbiota transplantation (FMT) and microbiome therapeutics, establishing the therapy as an effective treatment in IBD patients with recurrent C. difficile.”
Presented by the Bruce and Cynthia Sherman Charitable Foundation, the Sherman Prize is awarded to experts in the field of Crohn’s disease and ulcerative colitis who have exhibited their commitment to advancing inflammatory bowel disease care and have dedicated their careers to overcome these diseases.
Experts release new management strategies for malignant colorectal polyps
Early identification and removal of cancerous colorectal polyps is critical to preventing the progression of colorectal cancer and improving survival rates. The U.S. Multisociety Task Force (U.S. MSTF) on Colorectal Cancer has released new guidance for endoscopists on how to assess colorectal lesions for features associated with cancer, discuss how these factors guide management and outline when to advise surgery after malignant polyp removal.
Key recommendations from the U.S. Multisociety Task Force on Colorectal Cancer, which is comprised of leading experts representing AGA, ACG and ASGE, include:
1. Management of malignant polyps must begin with a thorough and knowledgeable endoscopic assessment designed to identify features of deep submucosal invasion.
2. In nonpedunculated lesions with features of deep submucosal invasion, endoscopic biopsy and tattooing should be followed by surgical resection.
3. Nonpedunculated lesions with high risk of superficial submucosal invasion should be considered for en bloc resection and proper specimen handling.
4. When pathology reports cancer in a lesion that was completely resected endoscopically, the decision to recommend surgery is based on polyp shape, whether there was en bloc resection and adequate histologic assessment, the presence or absence of unfavorable histologic features, the patient’s risk for surgical mortality and morbidity, and patient preferences.
For more information, review the full publication: Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps: Recommendations of the US Multi-Society Task Force on Colorectal Cancer. The U.S. MSTF recommendations are published jointly in Gastroenterology, The American Journal of Gastroenterology, and Gastrointestinal Endoscopy.
Early identification and removal of cancerous colorectal polyps is critical to preventing the progression of colorectal cancer and improving survival rates. The U.S. Multisociety Task Force (U.S. MSTF) on Colorectal Cancer has released new guidance for endoscopists on how to assess colorectal lesions for features associated with cancer, discuss how these factors guide management and outline when to advise surgery after malignant polyp removal.
Key recommendations from the U.S. Multisociety Task Force on Colorectal Cancer, which is comprised of leading experts representing AGA, ACG and ASGE, include:
1. Management of malignant polyps must begin with a thorough and knowledgeable endoscopic assessment designed to identify features of deep submucosal invasion.
2. In nonpedunculated lesions with features of deep submucosal invasion, endoscopic biopsy and tattooing should be followed by surgical resection.
3. Nonpedunculated lesions with high risk of superficial submucosal invasion should be considered for en bloc resection and proper specimen handling.
4. When pathology reports cancer in a lesion that was completely resected endoscopically, the decision to recommend surgery is based on polyp shape, whether there was en bloc resection and adequate histologic assessment, the presence or absence of unfavorable histologic features, the patient’s risk for surgical mortality and morbidity, and patient preferences.
For more information, review the full publication: Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps: Recommendations of the US Multi-Society Task Force on Colorectal Cancer. The U.S. MSTF recommendations are published jointly in Gastroenterology, The American Journal of Gastroenterology, and Gastrointestinal Endoscopy.
Early identification and removal of cancerous colorectal polyps is critical to preventing the progression of colorectal cancer and improving survival rates. The U.S. Multisociety Task Force (U.S. MSTF) on Colorectal Cancer has released new guidance for endoscopists on how to assess colorectal lesions for features associated with cancer, discuss how these factors guide management and outline when to advise surgery after malignant polyp removal.
Key recommendations from the U.S. Multisociety Task Force on Colorectal Cancer, which is comprised of leading experts representing AGA, ACG and ASGE, include:
1. Management of malignant polyps must begin with a thorough and knowledgeable endoscopic assessment designed to identify features of deep submucosal invasion.
2. In nonpedunculated lesions with features of deep submucosal invasion, endoscopic biopsy and tattooing should be followed by surgical resection.
3. Nonpedunculated lesions with high risk of superficial submucosal invasion should be considered for en bloc resection and proper specimen handling.
4. When pathology reports cancer in a lesion that was completely resected endoscopically, the decision to recommend surgery is based on polyp shape, whether there was en bloc resection and adequate histologic assessment, the presence or absence of unfavorable histologic features, the patient’s risk for surgical mortality and morbidity, and patient preferences.
For more information, review the full publication: Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps: Recommendations of the US Multi-Society Task Force on Colorectal Cancer. The U.S. MSTF recommendations are published jointly in Gastroenterology, The American Journal of Gastroenterology, and Gastrointestinal Endoscopy.
Immune checkpoint inhibitors don’t increase COVID-19 incidence or mortality, studies suggest
Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.
However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.
In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).
In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).
Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
COVID-19 incidence with ICIs
Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.
The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).
In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).
Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.
“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”
COVID-19 mortality with ICIs
For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.
Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.
In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.
Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).
At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.
The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.
“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.
“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
ICI therapy can continue, with precautions
“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.
“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.
However, the findings of the study by Tyan and colleagues are more “thought-provoking,” Dr. Doroshow said. She noted that a large study published in Nature Medicine showed previous ICI therapy in cancer patients with COVID-19 increased the risk for hospitalization or severe COVID-19 requiring high-flow oxygen or mechanical ventilation. The new study was much smaller and did not perform statistical comparisons for outcomes such as oxygen requirements.
“I would feel comfortable telling patients that the data suggests that ICI treatment does not increase their risk of COVID-19. However, if they were to be diagnosed with COVID-19, it is unclear whether their previous ICI treatment increases their risk for poor outcomes,” Dr. Doroshow said.
“I would feel comfortable continuing to treat patients with ICIs at this time, but because we know that patients with cancer are generally more likely to develop COVID-19 and have poor outcomes, it is critical that our patients be educated about social distancing and mask wearing to the extent that their living and working situations permit,” she added.
Mr. Pahalyants disclosed no relevant conflicts of interest, and his study did not receive any specific funding. Mr. Tyan disclosed that he is cofounder and chief science officer of Kinnos, and his study did not receive any specific funding. Dr. Doroshow disclosed no relevant conflicts of interest.
SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.
Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.
However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.
In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).
In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).
Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
COVID-19 incidence with ICIs
Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.
The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).
In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).
Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.
“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”
COVID-19 mortality with ICIs
For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.
Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.
In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.
Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).
At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.
The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.
“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.
“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
ICI therapy can continue, with precautions
“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.
“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.
However, the findings of the study by Tyan and colleagues are more “thought-provoking,” Dr. Doroshow said. She noted that a large study published in Nature Medicine showed previous ICI therapy in cancer patients with COVID-19 increased the risk for hospitalization or severe COVID-19 requiring high-flow oxygen or mechanical ventilation. The new study was much smaller and did not perform statistical comparisons for outcomes such as oxygen requirements.
“I would feel comfortable telling patients that the data suggests that ICI treatment does not increase their risk of COVID-19. However, if they were to be diagnosed with COVID-19, it is unclear whether their previous ICI treatment increases their risk for poor outcomes,” Dr. Doroshow said.
“I would feel comfortable continuing to treat patients with ICIs at this time, but because we know that patients with cancer are generally more likely to develop COVID-19 and have poor outcomes, it is critical that our patients be educated about social distancing and mask wearing to the extent that their living and working situations permit,” she added.
Mr. Pahalyants disclosed no relevant conflicts of interest, and his study did not receive any specific funding. Mr. Tyan disclosed that he is cofounder and chief science officer of Kinnos, and his study did not receive any specific funding. Dr. Doroshow disclosed no relevant conflicts of interest.
SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.
Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.
However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.
In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).
In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).
Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
COVID-19 incidence with ICIs
Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.
The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).
In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).
Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.
“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”
COVID-19 mortality with ICIs
For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.
Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.
In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.
Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).
At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.
The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.
“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.
“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
ICI therapy can continue, with precautions
“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.
“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.
However, the findings of the study by Tyan and colleagues are more “thought-provoking,” Dr. Doroshow said. She noted that a large study published in Nature Medicine showed previous ICI therapy in cancer patients with COVID-19 increased the risk for hospitalization or severe COVID-19 requiring high-flow oxygen or mechanical ventilation. The new study was much smaller and did not perform statistical comparisons for outcomes such as oxygen requirements.
“I would feel comfortable telling patients that the data suggests that ICI treatment does not increase their risk of COVID-19. However, if they were to be diagnosed with COVID-19, it is unclear whether their previous ICI treatment increases their risk for poor outcomes,” Dr. Doroshow said.
“I would feel comfortable continuing to treat patients with ICIs at this time, but because we know that patients with cancer are generally more likely to develop COVID-19 and have poor outcomes, it is critical that our patients be educated about social distancing and mask wearing to the extent that their living and working situations permit,” she added.
Mr. Pahalyants disclosed no relevant conflicts of interest, and his study did not receive any specific funding. Mr. Tyan disclosed that he is cofounder and chief science officer of Kinnos, and his study did not receive any specific funding. Dr. Doroshow disclosed no relevant conflicts of interest.
SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.
FROM SITC 2020
Rapid relief of opioid-induced constipation with MNTX
Subcutaneously administered methylnaltrexone (MNTX) (Relistor), a peripherally acting mu-opioid receptor antagonist, relieves opioid-induced constipation (OID) in both chronic, noncancer-related illness and cancer-related illness, a new analysis concludes.
“While these are two very different patient groups, the ability to have something to treat OIC in noncancer patients who stay on opioids for whatever reason helps, because [otherwise] these patients are not doing well,” said lead author Eric Shah, MD, motility director for the Dartmouth program at Dartmouth Hitchcock Health, Lebanon, N.H.
Importantly, peripherally acting mu-opioid receptor antagonists such as MNTX do not affect overall pain control to any significant extent, which is “reassuring,” he said in an interview.
These drugs decrease the constipating effects of opioids without reversing CNS-mediated opioid effects, he explained.
“Methylnaltrexone has already been approved for the treatment of OIC in adults with chronic noncancer pain as well as for OIC in adults with advanced illness who are receiving palliative care, which is often the case in patients with cancer-related pain,” he noted.
Dr. Shah discussed the new analysis during PAINWeek 2020, the American Society of Regional Anesthesia and Pain Medicine 19th Annual Pain Medicine Meeting.
The analysis was based on a review of data collected in two previously reported randomized, placebo-controlled studies (study 302 and 4000), which were used to gain approval.
The new analysis shows that “the drug works up front, and the effect is able to be maintained. I think the studies are clinically relevant in that patients are able to have a bowel movement quickly after you give them an injectable formulation when they are vomiting or otherwise can’t tolerate a pill and they are feeling miserable,” Dr. Shah commented. Many patients with OIC are constipated for reasons other than from opioid use. They often have other side effects from opioids, including bloating, nausea, and vomiting.
“When patients go to the emergency room, it’s not just that they are not able to have a bowel movement; they are often also vomiting, so it’s important to have agents that can be given in a manner that avoids the need for oral medication,” Dr. Shah said. MNTX is the only peripherally acting opioid antagonist available in a subcutaneous formulation.
Moreover, if patients are able to control these symptoms at home with an injectable formulation, they may not need to go to the ED for treatment of their gastrointestinal distress, he added.
Viable product
In a comment, Darren Brenner, MD, associate professor of medicine and surgery, Northwestern University, Chicago, who has worked with this subcutaneous formulation, said it is “definitely a viable product.
“The data presented here were in patients with advanced illness receiving palliative care when other laxatives have failed, and the difference and the potential benefit for MNTX is that it is the only peripherally acting mu-opioid receptor antagonist that is approved for advanced cancer,” he added. The other products that are currently approved, naloxegol (Movantik) and naldemedine (Symproic), are both indicated for chronic, noncancer pain.
The other potential benefit of subcutaneous MNTX is that it can work very rapidly for the patients who respond to it. “One of the things investigators did not mention in these two trials but which has been shown in previous studies is that almost half of patients who respond to this drug respond within the first 30 minutes of receiving the injection,” Dr. Brenner said in an interview.
This can be very beneficial in an emergency setting, because it may avoid having patients admitted to hospital. They can be discharged and sent home with enough drug to use on demand, Dr. Brenner suggested.
New analysis of data from studies 302 and 4000
Both studies were carried out in adults with advanced illness and OIC whose conditions were refractory to laxative use. Both of the studies were placebo controlled.
Study 302 involved 78 patients with cancer and 56 patients with noncancer-related OIC. MNTX was given at a dose of 0.15 mg/kg subcutaneously every other day for 2 weeks.
Study 4000 included 152 patients with cancer and OIC and 78 patients with noncancer-related OIC. In this study, the dose of MNTX was based on body weight. Seven or fewer doses of either 8 mg or 12 mg were given subcutaneously for 2 weeks.
The main endpoints of both studies was the proportion of patients who achieved a rescue-free laxation (RFL) response within 4 hours after the first dose and the proportion of patients with an RFL response within 4 hours for two or more of the first four doses within 24 hours.
Dr. Shah explained that RFL is a meaningful clinical endpoint. Patients could achieve a bowel movement with the two prespecified time endpoints in both studies.
Not all patients were hospitalized for OIC, Dr. Shah noted. Entry criteria were strict and included having fewer than three bowel movements during the previous week and no clinically significant laxation (defecation) within 48 hours of receiving the first dose of study drug.
“In both studies, a significantly greater proportion of patients treated with MNTX versus placebo achieved an RFL within 4 hours after the first dose among both cancer and noncancer patients,” the investigators reported.
Results were relatively comparable between cancer and noncancer patients who were treated for OIC in study 4000, the investigators noted.
Both studies were sponsored by Salix Pharmaceuticals. Dr. Shah has received travel fees from Salix Pharmaceuticals. Dr. Brenner has served as a consultant for Salix Pharmaceuticals, AstraZeneca, and Purdue Pharma. AstraZeneca developed naloxegol.
This article first appeared on Medscape.com.
Subcutaneously administered methylnaltrexone (MNTX) (Relistor), a peripherally acting mu-opioid receptor antagonist, relieves opioid-induced constipation (OID) in both chronic, noncancer-related illness and cancer-related illness, a new analysis concludes.
“While these are two very different patient groups, the ability to have something to treat OIC in noncancer patients who stay on opioids for whatever reason helps, because [otherwise] these patients are not doing well,” said lead author Eric Shah, MD, motility director for the Dartmouth program at Dartmouth Hitchcock Health, Lebanon, N.H.
Importantly, peripherally acting mu-opioid receptor antagonists such as MNTX do not affect overall pain control to any significant extent, which is “reassuring,” he said in an interview.
These drugs decrease the constipating effects of opioids without reversing CNS-mediated opioid effects, he explained.
“Methylnaltrexone has already been approved for the treatment of OIC in adults with chronic noncancer pain as well as for OIC in adults with advanced illness who are receiving palliative care, which is often the case in patients with cancer-related pain,” he noted.
Dr. Shah discussed the new analysis during PAINWeek 2020, the American Society of Regional Anesthesia and Pain Medicine 19th Annual Pain Medicine Meeting.
The analysis was based on a review of data collected in two previously reported randomized, placebo-controlled studies (study 302 and 4000), which were used to gain approval.
The new analysis shows that “the drug works up front, and the effect is able to be maintained. I think the studies are clinically relevant in that patients are able to have a bowel movement quickly after you give them an injectable formulation when they are vomiting or otherwise can’t tolerate a pill and they are feeling miserable,” Dr. Shah commented. Many patients with OIC are constipated for reasons other than from opioid use. They often have other side effects from opioids, including bloating, nausea, and vomiting.
“When patients go to the emergency room, it’s not just that they are not able to have a bowel movement; they are often also vomiting, so it’s important to have agents that can be given in a manner that avoids the need for oral medication,” Dr. Shah said. MNTX is the only peripherally acting opioid antagonist available in a subcutaneous formulation.
Moreover, if patients are able to control these symptoms at home with an injectable formulation, they may not need to go to the ED for treatment of their gastrointestinal distress, he added.
Viable product
In a comment, Darren Brenner, MD, associate professor of medicine and surgery, Northwestern University, Chicago, who has worked with this subcutaneous formulation, said it is “definitely a viable product.
“The data presented here were in patients with advanced illness receiving palliative care when other laxatives have failed, and the difference and the potential benefit for MNTX is that it is the only peripherally acting mu-opioid receptor antagonist that is approved for advanced cancer,” he added. The other products that are currently approved, naloxegol (Movantik) and naldemedine (Symproic), are both indicated for chronic, noncancer pain.
The other potential benefit of subcutaneous MNTX is that it can work very rapidly for the patients who respond to it. “One of the things investigators did not mention in these two trials but which has been shown in previous studies is that almost half of patients who respond to this drug respond within the first 30 minutes of receiving the injection,” Dr. Brenner said in an interview.
This can be very beneficial in an emergency setting, because it may avoid having patients admitted to hospital. They can be discharged and sent home with enough drug to use on demand, Dr. Brenner suggested.
New analysis of data from studies 302 and 4000
Both studies were carried out in adults with advanced illness and OIC whose conditions were refractory to laxative use. Both of the studies were placebo controlled.
Study 302 involved 78 patients with cancer and 56 patients with noncancer-related OIC. MNTX was given at a dose of 0.15 mg/kg subcutaneously every other day for 2 weeks.
Study 4000 included 152 patients with cancer and OIC and 78 patients with noncancer-related OIC. In this study, the dose of MNTX was based on body weight. Seven or fewer doses of either 8 mg or 12 mg were given subcutaneously for 2 weeks.
The main endpoints of both studies was the proportion of patients who achieved a rescue-free laxation (RFL) response within 4 hours after the first dose and the proportion of patients with an RFL response within 4 hours for two or more of the first four doses within 24 hours.
Dr. Shah explained that RFL is a meaningful clinical endpoint. Patients could achieve a bowel movement with the two prespecified time endpoints in both studies.
Not all patients were hospitalized for OIC, Dr. Shah noted. Entry criteria were strict and included having fewer than three bowel movements during the previous week and no clinically significant laxation (defecation) within 48 hours of receiving the first dose of study drug.
“In both studies, a significantly greater proportion of patients treated with MNTX versus placebo achieved an RFL within 4 hours after the first dose among both cancer and noncancer patients,” the investigators reported.
Results were relatively comparable between cancer and noncancer patients who were treated for OIC in study 4000, the investigators noted.
Both studies were sponsored by Salix Pharmaceuticals. Dr. Shah has received travel fees from Salix Pharmaceuticals. Dr. Brenner has served as a consultant for Salix Pharmaceuticals, AstraZeneca, and Purdue Pharma. AstraZeneca developed naloxegol.
This article first appeared on Medscape.com.
Subcutaneously administered methylnaltrexone (MNTX) (Relistor), a peripherally acting mu-opioid receptor antagonist, relieves opioid-induced constipation (OID) in both chronic, noncancer-related illness and cancer-related illness, a new analysis concludes.
“While these are two very different patient groups, the ability to have something to treat OIC in noncancer patients who stay on opioids for whatever reason helps, because [otherwise] these patients are not doing well,” said lead author Eric Shah, MD, motility director for the Dartmouth program at Dartmouth Hitchcock Health, Lebanon, N.H.
Importantly, peripherally acting mu-opioid receptor antagonists such as MNTX do not affect overall pain control to any significant extent, which is “reassuring,” he said in an interview.
These drugs decrease the constipating effects of opioids without reversing CNS-mediated opioid effects, he explained.
“Methylnaltrexone has already been approved for the treatment of OIC in adults with chronic noncancer pain as well as for OIC in adults with advanced illness who are receiving palliative care, which is often the case in patients with cancer-related pain,” he noted.
Dr. Shah discussed the new analysis during PAINWeek 2020, the American Society of Regional Anesthesia and Pain Medicine 19th Annual Pain Medicine Meeting.
The analysis was based on a review of data collected in two previously reported randomized, placebo-controlled studies (study 302 and 4000), which were used to gain approval.
The new analysis shows that “the drug works up front, and the effect is able to be maintained. I think the studies are clinically relevant in that patients are able to have a bowel movement quickly after you give them an injectable formulation when they are vomiting or otherwise can’t tolerate a pill and they are feeling miserable,” Dr. Shah commented. Many patients with OIC are constipated for reasons other than from opioid use. They often have other side effects from opioids, including bloating, nausea, and vomiting.
“When patients go to the emergency room, it’s not just that they are not able to have a bowel movement; they are often also vomiting, so it’s important to have agents that can be given in a manner that avoids the need for oral medication,” Dr. Shah said. MNTX is the only peripherally acting opioid antagonist available in a subcutaneous formulation.
Moreover, if patients are able to control these symptoms at home with an injectable formulation, they may not need to go to the ED for treatment of their gastrointestinal distress, he added.
Viable product
In a comment, Darren Brenner, MD, associate professor of medicine and surgery, Northwestern University, Chicago, who has worked with this subcutaneous formulation, said it is “definitely a viable product.
“The data presented here were in patients with advanced illness receiving palliative care when other laxatives have failed, and the difference and the potential benefit for MNTX is that it is the only peripherally acting mu-opioid receptor antagonist that is approved for advanced cancer,” he added. The other products that are currently approved, naloxegol (Movantik) and naldemedine (Symproic), are both indicated for chronic, noncancer pain.
The other potential benefit of subcutaneous MNTX is that it can work very rapidly for the patients who respond to it. “One of the things investigators did not mention in these two trials but which has been shown in previous studies is that almost half of patients who respond to this drug respond within the first 30 minutes of receiving the injection,” Dr. Brenner said in an interview.
This can be very beneficial in an emergency setting, because it may avoid having patients admitted to hospital. They can be discharged and sent home with enough drug to use on demand, Dr. Brenner suggested.
New analysis of data from studies 302 and 4000
Both studies were carried out in adults with advanced illness and OIC whose conditions were refractory to laxative use. Both of the studies were placebo controlled.
Study 302 involved 78 patients with cancer and 56 patients with noncancer-related OIC. MNTX was given at a dose of 0.15 mg/kg subcutaneously every other day for 2 weeks.
Study 4000 included 152 patients with cancer and OIC and 78 patients with noncancer-related OIC. In this study, the dose of MNTX was based on body weight. Seven or fewer doses of either 8 mg or 12 mg were given subcutaneously for 2 weeks.
The main endpoints of both studies was the proportion of patients who achieved a rescue-free laxation (RFL) response within 4 hours after the first dose and the proportion of patients with an RFL response within 4 hours for two or more of the first four doses within 24 hours.
Dr. Shah explained that RFL is a meaningful clinical endpoint. Patients could achieve a bowel movement with the two prespecified time endpoints in both studies.
Not all patients were hospitalized for OIC, Dr. Shah noted. Entry criteria were strict and included having fewer than three bowel movements during the previous week and no clinically significant laxation (defecation) within 48 hours of receiving the first dose of study drug.
“In both studies, a significantly greater proportion of patients treated with MNTX versus placebo achieved an RFL within 4 hours after the first dose among both cancer and noncancer patients,” the investigators reported.
Results were relatively comparable between cancer and noncancer patients who were treated for OIC in study 4000, the investigators noted.
Both studies were sponsored by Salix Pharmaceuticals. Dr. Shah has received travel fees from Salix Pharmaceuticals. Dr. Brenner has served as a consultant for Salix Pharmaceuticals, AstraZeneca, and Purdue Pharma. AstraZeneca developed naloxegol.
This article first appeared on Medscape.com.
Reduced cancer mortality with Medicaid expansion
Researchers reviewed data on 523,802 patients in the National Cancer Database who were diagnosed with cancer from 2012 through 2015. Slightly more than half of patients (55.2%) lived in Medicaid expansion states.
After expansion, mortality significantly decreased in expansion states (hazard ratio, 0.98; P = .008) but not in nonexpansion states (HR, 1.01; P = .43). The difference was significant in a difference-in-difference analysis (HR, 1.03; P = .01).
Across 69,000 patients with newly diagnosed cancer in Medicaid expansion states, the 2% decrease in the hazard of death would translate to 1,384 lives saved annually.
The benefit was primarily observed in patients with nonmetastatic cancer. For patients with stage I-III cancer, the risk of death was increased in nonexpansion states (HR, 1.05; P < .001) and unchanged in expansion states (HR, 0.99; P = .64). Mortality significantly improved in expansion states vs. nonexpansion states (HR, 1.05; P = .003).
For patients with stage IV cancer, both expansion and nonexpansion states had improvements in mortality, but the differences were not significant.
“Earlier stage at diagnosis appears to explain the mortality improvement,” wrote study author Miranda Lam, MD, of Harvard Medical School, Boston, and colleagues.
Clinical benefits, ‘no economic downside’
Under the Affordable Care Act, passed in 2010, states have the option of expanding Medicaid eligibility to adults with incomes at or below 138% of the federal poverty level. As of March 2020, 36 states and the District of Columbia had expanded Medicaid, with more than 20 million residents obtaining coverage.
Previous studies have associated Medicaid expansion with fewer patients being uninsured, increased cancer screening, and earlier stage of diagnosis, as well as reduced racial disparities in access to high-volume hospitals for cancer surgery and increased rates of cancer surgery among low-income patients.
“This study adds to an increasingly large body of research finding that Medicaid expansion has improved our ability to fight cancer,” said Coleman Drake, PhD, of the University of Pittsburgh, who was not involved in this study.
“Obtaining health insurance through Medicaid allows patients to receive recommended preventive cancer screenings, which explains the increase in early-stage diagnosis rates. Detecting cancer early is critical for successful cancer treatment,” Dr. Drake noted.
“It is hard to overstate the positive effects of Medicaid expansion on health outcomes. At the same time, concerns that Medicaid expansion would be costly to state governments’ budgets have not been realized. In short, Medicaid expansion yields many benefits and has no economic downside for state policymakers. Clinical and economic evidence make an overwhelming case for states to expand Medicaid,” Dr. Drake said.
Significant difference for lung cancer
Most patients in this study were women (73.6%), and the patients’ mean age was 54.8 years (range, 40-64 years). Patients had newly diagnosed breast cancer (52.2%), colorectal cancer (21.3%), and lung cancer (26.5%).
The benefits of Medicaid expansion persisted after adjustment for education, income, insurance, and race.
The lower mortality in expansion states compared with nonexpansion states was similar across all three cancer types. However, in stratified analyses, the difference was significant only for lung cancer (P = .03).
“Lung cancer has a higher mortality rate than breast and colorectal cancer, and with longer follow-up, it is possible that the lower mortality rates seen for breast and colorectal cancer may also become significant,” the authors wrote.
This research was funded by Harvard Catalyst, the Harvard Clinical and Translational Science Center, and the National Center for Advancing Translational Sciences at the National Institutes of Health. The investigators and Dr. Drake had no relevant disclosures.
SOURCE: Lam MB et al. JAMA Netw Open. 2020 Nov 2;3(11):e2024366.
Researchers reviewed data on 523,802 patients in the National Cancer Database who were diagnosed with cancer from 2012 through 2015. Slightly more than half of patients (55.2%) lived in Medicaid expansion states.
After expansion, mortality significantly decreased in expansion states (hazard ratio, 0.98; P = .008) but not in nonexpansion states (HR, 1.01; P = .43). The difference was significant in a difference-in-difference analysis (HR, 1.03; P = .01).
Across 69,000 patients with newly diagnosed cancer in Medicaid expansion states, the 2% decrease in the hazard of death would translate to 1,384 lives saved annually.
The benefit was primarily observed in patients with nonmetastatic cancer. For patients with stage I-III cancer, the risk of death was increased in nonexpansion states (HR, 1.05; P < .001) and unchanged in expansion states (HR, 0.99; P = .64). Mortality significantly improved in expansion states vs. nonexpansion states (HR, 1.05; P = .003).
For patients with stage IV cancer, both expansion and nonexpansion states had improvements in mortality, but the differences were not significant.
“Earlier stage at diagnosis appears to explain the mortality improvement,” wrote study author Miranda Lam, MD, of Harvard Medical School, Boston, and colleagues.
Clinical benefits, ‘no economic downside’
Under the Affordable Care Act, passed in 2010, states have the option of expanding Medicaid eligibility to adults with incomes at or below 138% of the federal poverty level. As of March 2020, 36 states and the District of Columbia had expanded Medicaid, with more than 20 million residents obtaining coverage.
Previous studies have associated Medicaid expansion with fewer patients being uninsured, increased cancer screening, and earlier stage of diagnosis, as well as reduced racial disparities in access to high-volume hospitals for cancer surgery and increased rates of cancer surgery among low-income patients.
“This study adds to an increasingly large body of research finding that Medicaid expansion has improved our ability to fight cancer,” said Coleman Drake, PhD, of the University of Pittsburgh, who was not involved in this study.
“Obtaining health insurance through Medicaid allows patients to receive recommended preventive cancer screenings, which explains the increase in early-stage diagnosis rates. Detecting cancer early is critical for successful cancer treatment,” Dr. Drake noted.
“It is hard to overstate the positive effects of Medicaid expansion on health outcomes. At the same time, concerns that Medicaid expansion would be costly to state governments’ budgets have not been realized. In short, Medicaid expansion yields many benefits and has no economic downside for state policymakers. Clinical and economic evidence make an overwhelming case for states to expand Medicaid,” Dr. Drake said.
Significant difference for lung cancer
Most patients in this study were women (73.6%), and the patients’ mean age was 54.8 years (range, 40-64 years). Patients had newly diagnosed breast cancer (52.2%), colorectal cancer (21.3%), and lung cancer (26.5%).
The benefits of Medicaid expansion persisted after adjustment for education, income, insurance, and race.
The lower mortality in expansion states compared with nonexpansion states was similar across all three cancer types. However, in stratified analyses, the difference was significant only for lung cancer (P = .03).
“Lung cancer has a higher mortality rate than breast and colorectal cancer, and with longer follow-up, it is possible that the lower mortality rates seen for breast and colorectal cancer may also become significant,” the authors wrote.
This research was funded by Harvard Catalyst, the Harvard Clinical and Translational Science Center, and the National Center for Advancing Translational Sciences at the National Institutes of Health. The investigators and Dr. Drake had no relevant disclosures.
SOURCE: Lam MB et al. JAMA Netw Open. 2020 Nov 2;3(11):e2024366.
Researchers reviewed data on 523,802 patients in the National Cancer Database who were diagnosed with cancer from 2012 through 2015. Slightly more than half of patients (55.2%) lived in Medicaid expansion states.
After expansion, mortality significantly decreased in expansion states (hazard ratio, 0.98; P = .008) but not in nonexpansion states (HR, 1.01; P = .43). The difference was significant in a difference-in-difference analysis (HR, 1.03; P = .01).
Across 69,000 patients with newly diagnosed cancer in Medicaid expansion states, the 2% decrease in the hazard of death would translate to 1,384 lives saved annually.
The benefit was primarily observed in patients with nonmetastatic cancer. For patients with stage I-III cancer, the risk of death was increased in nonexpansion states (HR, 1.05; P < .001) and unchanged in expansion states (HR, 0.99; P = .64). Mortality significantly improved in expansion states vs. nonexpansion states (HR, 1.05; P = .003).
For patients with stage IV cancer, both expansion and nonexpansion states had improvements in mortality, but the differences were not significant.
“Earlier stage at diagnosis appears to explain the mortality improvement,” wrote study author Miranda Lam, MD, of Harvard Medical School, Boston, and colleagues.
Clinical benefits, ‘no economic downside’
Under the Affordable Care Act, passed in 2010, states have the option of expanding Medicaid eligibility to adults with incomes at or below 138% of the federal poverty level. As of March 2020, 36 states and the District of Columbia had expanded Medicaid, with more than 20 million residents obtaining coverage.
Previous studies have associated Medicaid expansion with fewer patients being uninsured, increased cancer screening, and earlier stage of diagnosis, as well as reduced racial disparities in access to high-volume hospitals for cancer surgery and increased rates of cancer surgery among low-income patients.
“This study adds to an increasingly large body of research finding that Medicaid expansion has improved our ability to fight cancer,” said Coleman Drake, PhD, of the University of Pittsburgh, who was not involved in this study.
“Obtaining health insurance through Medicaid allows patients to receive recommended preventive cancer screenings, which explains the increase in early-stage diagnosis rates. Detecting cancer early is critical for successful cancer treatment,” Dr. Drake noted.
“It is hard to overstate the positive effects of Medicaid expansion on health outcomes. At the same time, concerns that Medicaid expansion would be costly to state governments’ budgets have not been realized. In short, Medicaid expansion yields many benefits and has no economic downside for state policymakers. Clinical and economic evidence make an overwhelming case for states to expand Medicaid,” Dr. Drake said.
Significant difference for lung cancer
Most patients in this study were women (73.6%), and the patients’ mean age was 54.8 years (range, 40-64 years). Patients had newly diagnosed breast cancer (52.2%), colorectal cancer (21.3%), and lung cancer (26.5%).
The benefits of Medicaid expansion persisted after adjustment for education, income, insurance, and race.
The lower mortality in expansion states compared with nonexpansion states was similar across all three cancer types. However, in stratified analyses, the difference was significant only for lung cancer (P = .03).
“Lung cancer has a higher mortality rate than breast and colorectal cancer, and with longer follow-up, it is possible that the lower mortality rates seen for breast and colorectal cancer may also become significant,” the authors wrote.
This research was funded by Harvard Catalyst, the Harvard Clinical and Translational Science Center, and the National Center for Advancing Translational Sciences at the National Institutes of Health. The investigators and Dr. Drake had no relevant disclosures.
SOURCE: Lam MB et al. JAMA Netw Open. 2020 Nov 2;3(11):e2024366.
FROM JAMA OPEN NETWORK
Survey finds Black, Hispanic patients may prefer race-concordant dermatologists, highlighting opportunities for changes in education and practice
, according to a patient survey.
In the survey, 42% of self-identified Black patients and 44% of self-identified Hispanic patients assigned some level of importance to the race or ethnicity of their dermatologist. Of patients self-identified as White, the figure was 2%, which was significantly lower (P less than .001).
Responses to the survey indicated that there is concern among non-White patients that White physicians are not fully sensitive to the clinical issues presented by their skin type. For example, 22% of Hispanic patients and 21% of Black patients agreed that a race-concordant physician would be better trained to treat their skin.
The results of the survey were recently published in a Research Letter in the Journal of the American Academy of Dermatology.
When patients were asked to agree or disagree with the statement that non-White patients receive the same quality of care as White patients, about a third disagreed, “but about half said they were unsure, which I interpret basically as a negative answer,” reported the lead author, Adam Friedman, MD, professor and interim chair of the department of dermatology at George Washington University, Washington.
“These data are a call to action. Certainly, we need to diversify our workforce to mirror the overall population, but we can also do more to improve training for dermatologic diseases across skin types,” Dr. Friedman said in an interview.
“Ensuring all skin types are represented in all dermatologic education, from resident book clubs to the national stage is but one step to making dermatology more inclusive and prepared to care for all patients,” he added.
Ninety-two patients receiving dermatology care at Dr. Friedman’s institution completed the survey. Fifty identified themselves as White, nine as Hispanic, and 33 as Black. Allowing patients to self-identify race was an important feature of this survey, according to Dr. Friedman.
“Something I really struggle with is terminology. Are race and ethnicity the appropriate terms when discussing different skin types and tones? It is so easy to misuse even validated tools. The Fitzpatrick Scale, for example, requires patients to relay how easily they burn, but reveals nothing about how patients refer to their skin tone,” Dr. Friedman explained. “We need to reset how we characterize and categorize skin types.”
Among those who assigned at least some importance to having a dermatologist of the same race or ethnicity, the most common reason was that such physicians “are better able to listen and relate to me.” Thirty percent of Black patients and 22% of Hispanic patients agreed with this statement. The perception that such physicians are better trained to treat non-White skin was the next most common reason.
The results of the survey emphasize the importance of ensuring that there is comprehensive training in managing all skin types and that physicians receive rigorous implicit bias and cultural sensitivity training in order to win patient trust, according to Dr. Friedman. He suggested that the perception that White physicians might not provide optimal care to non-White patients by study participants “has some validity. Structural racism in medicine is well-documented, and dermatologists have already begun to combat this on several fronts.”
In fact, the process of conducting and analyzing data from this survey proved to be its own lesson in sociocultural sensitivity, he said.
After a draft completed peer review and was accepted for publication, Dr. Friedman was confronted with numerous criticisms of the language that was used. In particular, one of his former residents, Misty Eleryan, MD, who is now a Mohs Fellow at the University of California, Los Angeles, was instrumental in pointing out problems. Ultimately, he withdrew the paper to rephrase the findings.
“It was not until then that I also learned that there is a JAAD Sensitivity Workgroup, which was very helpful in identifying issues we had overlooked,” Dr. Friedman said. For example, he had used the term “minorities” for non-White populations, which is not only inaccurate in many situations but has a pejorative undertone.
“It is important to recognize that the impact is more important than the intention,” said Dr. Friedman, who reported that he learned a lot in this process.
It is the need for this type of augmented sensitivity that the survey underscores, he added. He called for cultural sensitivity to be part of medical training to undo unrecognized bias, and said, “We need to understand how our patients perceive us.”
SOURCE: Friedman A et al. J Am Acad Dermatol. 2020 Sep 16;S0190-9622(20)32620-7. doi: 10.1016/j.jaad.2020.09.032.
, according to a patient survey.
In the survey, 42% of self-identified Black patients and 44% of self-identified Hispanic patients assigned some level of importance to the race or ethnicity of their dermatologist. Of patients self-identified as White, the figure was 2%, which was significantly lower (P less than .001).
Responses to the survey indicated that there is concern among non-White patients that White physicians are not fully sensitive to the clinical issues presented by their skin type. For example, 22% of Hispanic patients and 21% of Black patients agreed that a race-concordant physician would be better trained to treat their skin.
The results of the survey were recently published in a Research Letter in the Journal of the American Academy of Dermatology.
When patients were asked to agree or disagree with the statement that non-White patients receive the same quality of care as White patients, about a third disagreed, “but about half said they were unsure, which I interpret basically as a negative answer,” reported the lead author, Adam Friedman, MD, professor and interim chair of the department of dermatology at George Washington University, Washington.
“These data are a call to action. Certainly, we need to diversify our workforce to mirror the overall population, but we can also do more to improve training for dermatologic diseases across skin types,” Dr. Friedman said in an interview.
“Ensuring all skin types are represented in all dermatologic education, from resident book clubs to the national stage is but one step to making dermatology more inclusive and prepared to care for all patients,” he added.
Ninety-two patients receiving dermatology care at Dr. Friedman’s institution completed the survey. Fifty identified themselves as White, nine as Hispanic, and 33 as Black. Allowing patients to self-identify race was an important feature of this survey, according to Dr. Friedman.
“Something I really struggle with is terminology. Are race and ethnicity the appropriate terms when discussing different skin types and tones? It is so easy to misuse even validated tools. The Fitzpatrick Scale, for example, requires patients to relay how easily they burn, but reveals nothing about how patients refer to their skin tone,” Dr. Friedman explained. “We need to reset how we characterize and categorize skin types.”
Among those who assigned at least some importance to having a dermatologist of the same race or ethnicity, the most common reason was that such physicians “are better able to listen and relate to me.” Thirty percent of Black patients and 22% of Hispanic patients agreed with this statement. The perception that such physicians are better trained to treat non-White skin was the next most common reason.
The results of the survey emphasize the importance of ensuring that there is comprehensive training in managing all skin types and that physicians receive rigorous implicit bias and cultural sensitivity training in order to win patient trust, according to Dr. Friedman. He suggested that the perception that White physicians might not provide optimal care to non-White patients by study participants “has some validity. Structural racism in medicine is well-documented, and dermatologists have already begun to combat this on several fronts.”
In fact, the process of conducting and analyzing data from this survey proved to be its own lesson in sociocultural sensitivity, he said.
After a draft completed peer review and was accepted for publication, Dr. Friedman was confronted with numerous criticisms of the language that was used. In particular, one of his former residents, Misty Eleryan, MD, who is now a Mohs Fellow at the University of California, Los Angeles, was instrumental in pointing out problems. Ultimately, he withdrew the paper to rephrase the findings.
“It was not until then that I also learned that there is a JAAD Sensitivity Workgroup, which was very helpful in identifying issues we had overlooked,” Dr. Friedman said. For example, he had used the term “minorities” for non-White populations, which is not only inaccurate in many situations but has a pejorative undertone.
“It is important to recognize that the impact is more important than the intention,” said Dr. Friedman, who reported that he learned a lot in this process.
It is the need for this type of augmented sensitivity that the survey underscores, he added. He called for cultural sensitivity to be part of medical training to undo unrecognized bias, and said, “We need to understand how our patients perceive us.”
SOURCE: Friedman A et al. J Am Acad Dermatol. 2020 Sep 16;S0190-9622(20)32620-7. doi: 10.1016/j.jaad.2020.09.032.
, according to a patient survey.
In the survey, 42% of self-identified Black patients and 44% of self-identified Hispanic patients assigned some level of importance to the race or ethnicity of their dermatologist. Of patients self-identified as White, the figure was 2%, which was significantly lower (P less than .001).
Responses to the survey indicated that there is concern among non-White patients that White physicians are not fully sensitive to the clinical issues presented by their skin type. For example, 22% of Hispanic patients and 21% of Black patients agreed that a race-concordant physician would be better trained to treat their skin.
The results of the survey were recently published in a Research Letter in the Journal of the American Academy of Dermatology.
When patients were asked to agree or disagree with the statement that non-White patients receive the same quality of care as White patients, about a third disagreed, “but about half said they were unsure, which I interpret basically as a negative answer,” reported the lead author, Adam Friedman, MD, professor and interim chair of the department of dermatology at George Washington University, Washington.
“These data are a call to action. Certainly, we need to diversify our workforce to mirror the overall population, but we can also do more to improve training for dermatologic diseases across skin types,” Dr. Friedman said in an interview.
“Ensuring all skin types are represented in all dermatologic education, from resident book clubs to the national stage is but one step to making dermatology more inclusive and prepared to care for all patients,” he added.
Ninety-two patients receiving dermatology care at Dr. Friedman’s institution completed the survey. Fifty identified themselves as White, nine as Hispanic, and 33 as Black. Allowing patients to self-identify race was an important feature of this survey, according to Dr. Friedman.
“Something I really struggle with is terminology. Are race and ethnicity the appropriate terms when discussing different skin types and tones? It is so easy to misuse even validated tools. The Fitzpatrick Scale, for example, requires patients to relay how easily they burn, but reveals nothing about how patients refer to their skin tone,” Dr. Friedman explained. “We need to reset how we characterize and categorize skin types.”
Among those who assigned at least some importance to having a dermatologist of the same race or ethnicity, the most common reason was that such physicians “are better able to listen and relate to me.” Thirty percent of Black patients and 22% of Hispanic patients agreed with this statement. The perception that such physicians are better trained to treat non-White skin was the next most common reason.
The results of the survey emphasize the importance of ensuring that there is comprehensive training in managing all skin types and that physicians receive rigorous implicit bias and cultural sensitivity training in order to win patient trust, according to Dr. Friedman. He suggested that the perception that White physicians might not provide optimal care to non-White patients by study participants “has some validity. Structural racism in medicine is well-documented, and dermatologists have already begun to combat this on several fronts.”
In fact, the process of conducting and analyzing data from this survey proved to be its own lesson in sociocultural sensitivity, he said.
After a draft completed peer review and was accepted for publication, Dr. Friedman was confronted with numerous criticisms of the language that was used. In particular, one of his former residents, Misty Eleryan, MD, who is now a Mohs Fellow at the University of California, Los Angeles, was instrumental in pointing out problems. Ultimately, he withdrew the paper to rephrase the findings.
“It was not until then that I also learned that there is a JAAD Sensitivity Workgroup, which was very helpful in identifying issues we had overlooked,” Dr. Friedman said. For example, he had used the term “minorities” for non-White populations, which is not only inaccurate in many situations but has a pejorative undertone.
“It is important to recognize that the impact is more important than the intention,” said Dr. Friedman, who reported that he learned a lot in this process.
It is the need for this type of augmented sensitivity that the survey underscores, he added. He called for cultural sensitivity to be part of medical training to undo unrecognized bias, and said, “We need to understand how our patients perceive us.”
SOURCE: Friedman A et al. J Am Acad Dermatol. 2020 Sep 16;S0190-9622(20)32620-7. doi: 10.1016/j.jaad.2020.09.032.
Prophylactic HIV treatment in female STI patients is rare
reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.
In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
Medicaid patients were more likely to be tested for HIV
A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.
STI diagnosis is a significant indicator of future HIV
Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”
The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.
Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.
In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.
“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
PrEP is an important, simple strategy for reducing HIV transmission
“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).
Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.
Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.
Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.
Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.
“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.
The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.
reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.
In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
Medicaid patients were more likely to be tested for HIV
A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.
STI diagnosis is a significant indicator of future HIV
Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”
The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.
Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.
In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.
“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
PrEP is an important, simple strategy for reducing HIV transmission
“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).
Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.
Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.
Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.
Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.
“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.
The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.
reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.
In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
Medicaid patients were more likely to be tested for HIV
A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.
STI diagnosis is a significant indicator of future HIV
Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”
The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.
Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.
In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.
“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
PrEP is an important, simple strategy for reducing HIV transmission
“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).
Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.
Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.
Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.
Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.
“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.
The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.
FROM OBSTETRICS & GYNECOLOGY