The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.
 

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.

The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.
 

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.

The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.
 

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.

Evaluation and Management (E/M) coding and guidelines are about to undergo the most significant changes since their implementation in the 1990s. For now, the changes are limited to new and established outpatient visits (CPT codes 99202-99205, 99211-99215) and will take place as of Jan. 1, 2021. Changes to all E/M codes are anticipated in the coming years.

The changes to the new and established office/outpatient codes will impact everyone in health care who assigns codes, manages health information, or pays claims including physicians and qualified health professionals, coders, health information managers, payers, health systems, and hospitals. The American Medical Association (AMA) has already released a preview of the CPT 2021 changes as well as free E/M education modules. They are planning to release more educational resources in the near future.
 

Why were changes needed?

The AMA developed the 2021 E/M changes in response to interest from the Centers for Medicare & Medicaid Services (CMS) in reducing physician burden, simplifying documentation requirements, and making changes to payments for the E/M codes. CMS’s initial proposal was to collapse office visit E/M levels 2-5 to a single payment. While the new rates would have provided a modest increase for level 2 and 3 E/M codes, they would have cut reimbursement for the top-level codes by more than 50%. There was concern that these changes would adversely affect physicians caring for complex patients across medical specialties. There was an outcry from the physician community opposing CMS’s proposal, and the agency agreed to get more input from the public before moving forward.

The AMA worked with stakeholders, including the AGA and our sister GI societies, to create E/M guidelines that decrease documentation requirements while also continuing to differentiate payment based on complexity of care. CMS announced in the 2020 Medicare Physician Fee Schedule (MPFS) final rule that it would adopt the AMA’s proposal as well as their recommended relative values for 2021 CPT E/M codes. Of note, there will be modest payment increases for most office E/M codes beginning Jan. 1, 2021, which may benefit those who manage patients with complex conditions.

In sum, what are the 2021 E/M changes

While there will be many changes to office/outpatient E/M visits, the most significant are deletion of code 99201 (Level 1 new patient visit), addition of a 15-minute prolonged services code that can be reported with 99205 and 99215, and the following restructuring of office visit code selection:

1. Elimination of history and physical as elements for code selection: While obtaining a pertinent history and performing a relevant physical exam are clinically necessary and contribute to both time and medical decision making, these elements will not factor in to code selection. Instead, the code level will be determined solely by medical decision making or time.

2. Choice of using medical decision making (MDM) or total time as the basis of E/M level documentation:

• MDM. While there will still be three MDM subcomponents (number/complexity of problems, data, and risk), extensive edits were made to the ways in which these elements are defined and tallied.
• Time. The definition of time is now minimum time, not typical time or “face-to-face” time. Minimum time represents total physician/qualified health care professional time on the date of service. This redefinition of time allows Medicare to better recognize the work involved in non–face-to-face services like care coordination and record review. Of note, these definitions only apply when code selection is based on time and not MDM.

3. Modification of the criteria for MDM: The current CMS Table of Risk was used as a foundation for designing the revised required elements for MDM.

• Terms. Removed ambiguous terms (e.g., “mild”) and defined previously ambiguous concepts (e.g., “acute or chronic illness with systemic symptoms”).
• Definitions. Defined important terms, such as “independent historian.”
• Data elements. Re-defined the data elements to move away from simply adding up tasks to focusing on how those tasks affect the management of the patient (e.g., independent interpretation of a test performed by another provider and/or discussion of test interpretation with another physician).

CMS also plans to add a new Healthcare Common Procedure Coding System (HCPCS) add-on code as of Jan. 1, 2021, that can be used to recognize additional resource costs that are inherent in treating complex patients.

• GPCX1 - Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex chronic condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established.).

GPC1X can be reported with all levels of E/M office/outpatient codes in which care of a patient’s single, serious, or complex chronic condition is the focus. CMS plans to reimburse GPC1X at 0.33 RVUs (about $12).
 

Who do these changes apply to?

The changes to the E/M office/outpatient CPT codes and guidelines for new and established patients apply to all traditional Medicare and Medicare Advantage plans, Medicaid, and all commercial payers. E/M HCPCS codes apply to Medicare, Medicare Advantage plans, and Medicaid only; commercial payers are not required to accept HCPCS codes.

What should you do?

Visit the AMA E/M Microsite; there you will find the AMA’s early release of the 2021 E/M coding and guideline changes, the AMA E/M learning module and future resources on the use of time and MDM that are expected to be released in March.

AMA E/M Microsite: https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management

2021 E/M changes: https://www.ama-assn.org/system/files/2019-06/cpt-office-prolonged-svs-code-changes.pdf

AMA E/M learning module: https://edhub.ama-assn.org/interactive/18057429

AMA MDM table: https://www.ama-assn.org/system/files/2019-06/cpt-revised-mdm-grid.pdf

Connect with your coders and/or medical billing company to create a plan for training physicians and staff to ensure a smooth transition on Jan. 1, 2021.

Contact your Electronic Health Records (EHR) vendor to confirm the system your practice uses will be ready to implement the new E/M coding and guidelines changes on Jan. 1, 2021.

Run an analysis using the new E/M office/outpatient payment rates recommended by the AMA for 2021 (https://www.ama-assn.org/about/rvs-update-committee-ruc/ruc-recommendations-minutes-voting) for each of your practice’s contracted payers to determine if your practice will benefit from the new rates. While CMS has proposed to accept the AMA recommended rates, this will not be finalized until CMS publishes the 2021 proposed rule in early July 2020.

Once CMS confirms its decision, reach out to your payers to negotiate implementing the new E/M rates starting in 2021.

With changes this big, we encourage you to prepare early. Watch for more information on the 2021 E/M changes in Washington Insider and AGA eDigest.
 

Dr. Kuo is the AGA’s Advisor to the AMA CPT Editorial Panel and a member of the AGA Practice Management and Economics Committee’s (PMEC) Coverage and Reimbursement Subcommittee (CRS) and assistant professor of medicine and gastroenterology, Harvard Medical School and Massachusetts General Hospital, Boston; Dr. Losurdo is the AGA’s Alternate Advisor to the AMA CPT Editorial Panel, a member of the AGA PMEC’s CRS, and Managing Partner and medical director of Illinois Gastroenterology Group, Elgin, Ill.; Dr. Mehta is the AGA’s advisor to the AMA RVS Update Committee (RUC), a member of the AGA PMEC’s CRS, and assistant professor of medicine at the University of Pennsylvania, Philadelphia; and Dr. Garcia is the AGA’s Alternate Advisor to the AMA RUC, a member of the AGA PMEC’s CRS, and assistant professor of medicine and gastroenterology at Stanford (Calif.) University. There were no conflicts of interest.

Evaluation and Management (E/M) coding and guidelines are about to undergo the most significant changes since their implementation in the 1990s. For now, the changes are limited to new and established outpatient visits (CPT codes 99202-99205, 99211-99215) and will take place as of Jan. 1, 2021. Changes to all E/M codes are anticipated in the coming years.

The changes to the new and established office/outpatient codes will impact everyone in health care who assigns codes, manages health information, or pays claims including physicians and qualified health professionals, coders, health information managers, payers, health systems, and hospitals. The American Medical Association (AMA) has already released a preview of the CPT 2021 changes as well as free E/M education modules. They are planning to release more educational resources in the near future.
 

Why were changes needed?

The AMA developed the 2021 E/M changes in response to interest from the Centers for Medicare & Medicaid Services (CMS) in reducing physician burden, simplifying documentation requirements, and making changes to payments for the E/M codes. CMS’s initial proposal was to collapse office visit E/M levels 2-5 to a single payment. While the new rates would have provided a modest increase for level 2 and 3 E/M codes, they would have cut reimbursement for the top-level codes by more than 50%. There was concern that these changes would adversely affect physicians caring for complex patients across medical specialties. There was an outcry from the physician community opposing CMS’s proposal, and the agency agreed to get more input from the public before moving forward.

The AMA worked with stakeholders, including the AGA and our sister GI societies, to create E/M guidelines that decrease documentation requirements while also continuing to differentiate payment based on complexity of care. CMS announced in the 2020 Medicare Physician Fee Schedule (MPFS) final rule that it would adopt the AMA’s proposal as well as their recommended relative values for 2021 CPT E/M codes. Of note, there will be modest payment increases for most office E/M codes beginning Jan. 1, 2021, which may benefit those who manage patients with complex conditions.

In sum, what are the 2021 E/M changes

While there will be many changes to office/outpatient E/M visits, the most significant are deletion of code 99201 (Level 1 new patient visit), addition of a 15-minute prolonged services code that can be reported with 99205 and 99215, and the following restructuring of office visit code selection:

1. Elimination of history and physical as elements for code selection: While obtaining a pertinent history and performing a relevant physical exam are clinically necessary and contribute to both time and medical decision making, these elements will not factor in to code selection. Instead, the code level will be determined solely by medical decision making or time.

2. Choice of using medical decision making (MDM) or total time as the basis of E/M level documentation:

• MDM. While there will still be three MDM subcomponents (number/complexity of problems, data, and risk), extensive edits were made to the ways in which these elements are defined and tallied.
• Time. The definition of time is now minimum time, not typical time or “face-to-face” time. Minimum time represents total physician/qualified health care professional time on the date of service. This redefinition of time allows Medicare to better recognize the work involved in non–face-to-face services like care coordination and record review. Of note, these definitions only apply when code selection is based on time and not MDM.

3. Modification of the criteria for MDM: The current CMS Table of Risk was used as a foundation for designing the revised required elements for MDM.

• Terms. Removed ambiguous terms (e.g., “mild”) and defined previously ambiguous concepts (e.g., “acute or chronic illness with systemic symptoms”).
• Definitions. Defined important terms, such as “independent historian.”
• Data elements. Re-defined the data elements to move away from simply adding up tasks to focusing on how those tasks affect the management of the patient (e.g., independent interpretation of a test performed by another provider and/or discussion of test interpretation with another physician).

CMS also plans to add a new Healthcare Common Procedure Coding System (HCPCS) add-on code as of Jan. 1, 2021, that can be used to recognize additional resource costs that are inherent in treating complex patients.

• GPCX1 - Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex chronic condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established.).

GPC1X can be reported with all levels of E/M office/outpatient codes in which care of a patient’s single, serious, or complex chronic condition is the focus. CMS plans to reimburse GPC1X at 0.33 RVUs (about $12).
 

Who do these changes apply to?

The changes to the E/M office/outpatient CPT codes and guidelines for new and established patients apply to all traditional Medicare and Medicare Advantage plans, Medicaid, and all commercial payers. E/M HCPCS codes apply to Medicare, Medicare Advantage plans, and Medicaid only; commercial payers are not required to accept HCPCS codes.

What should you do?

Visit the AMA E/M Microsite; there you will find the AMA’s early release of the 2021 E/M coding and guideline changes, the AMA E/M learning module and future resources on the use of time and MDM that are expected to be released in March.

AMA E/M Microsite: https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management

2021 E/M changes: https://www.ama-assn.org/system/files/2019-06/cpt-office-prolonged-svs-code-changes.pdf

AMA E/M learning module: https://edhub.ama-assn.org/interactive/18057429

AMA MDM table: https://www.ama-assn.org/system/files/2019-06/cpt-revised-mdm-grid.pdf

Connect with your coders and/or medical billing company to create a plan for training physicians and staff to ensure a smooth transition on Jan. 1, 2021.

Contact your Electronic Health Records (EHR) vendor to confirm the system your practice uses will be ready to implement the new E/M coding and guidelines changes on Jan. 1, 2021.

Run an analysis using the new E/M office/outpatient payment rates recommended by the AMA for 2021 (https://www.ama-assn.org/about/rvs-update-committee-ruc/ruc-recommendations-minutes-voting) for each of your practice’s contracted payers to determine if your practice will benefit from the new rates. While CMS has proposed to accept the AMA recommended rates, this will not be finalized until CMS publishes the 2021 proposed rule in early July 2020.

Once CMS confirms its decision, reach out to your payers to negotiate implementing the new E/M rates starting in 2021.

With changes this big, we encourage you to prepare early. Watch for more information on the 2021 E/M changes in Washington Insider and AGA eDigest.
 

Dr. Kuo is the AGA’s Advisor to the AMA CPT Editorial Panel and a member of the AGA Practice Management and Economics Committee’s (PMEC) Coverage and Reimbursement Subcommittee (CRS) and assistant professor of medicine and gastroenterology, Harvard Medical School and Massachusetts General Hospital, Boston; Dr. Losurdo is the AGA’s Alternate Advisor to the AMA CPT Editorial Panel, a member of the AGA PMEC’s CRS, and Managing Partner and medical director of Illinois Gastroenterology Group, Elgin, Ill.; Dr. Mehta is the AGA’s advisor to the AMA RVS Update Committee (RUC), a member of the AGA PMEC’s CRS, and assistant professor of medicine at the University of Pennsylvania, Philadelphia; and Dr. Garcia is the AGA’s Alternate Advisor to the AMA RUC, a member of the AGA PMEC’s CRS, and assistant professor of medicine and gastroenterology at Stanford (Calif.) University. There were no conflicts of interest.

Evaluation and Management (E/M) coding and guidelines are about to undergo the most significant changes since their implementation in the 1990s. For now, the changes are limited to new and established outpatient visits (CPT codes 99202-99205, 99211-99215) and will take place as of Jan. 1, 2021. Changes to all E/M codes are anticipated in the coming years.

The changes to the new and established office/outpatient codes will impact everyone in health care who assigns codes, manages health information, or pays claims including physicians and qualified health professionals, coders, health information managers, payers, health systems, and hospitals. The American Medical Association (AMA) has already released a preview of the CPT 2021 changes as well as free E/M education modules. They are planning to release more educational resources in the near future.
 

Why were changes needed?

The AMA developed the 2021 E/M changes in response to interest from the Centers for Medicare & Medicaid Services (CMS) in reducing physician burden, simplifying documentation requirements, and making changes to payments for the E/M codes. CMS’s initial proposal was to collapse office visit E/M levels 2-5 to a single payment. While the new rates would have provided a modest increase for level 2 and 3 E/M codes, they would have cut reimbursement for the top-level codes by more than 50%. There was concern that these changes would adversely affect physicians caring for complex patients across medical specialties. There was an outcry from the physician community opposing CMS’s proposal, and the agency agreed to get more input from the public before moving forward.

The AMA worked with stakeholders, including the AGA and our sister GI societies, to create E/M guidelines that decrease documentation requirements while also continuing to differentiate payment based on complexity of care. CMS announced in the 2020 Medicare Physician Fee Schedule (MPFS) final rule that it would adopt the AMA’s proposal as well as their recommended relative values for 2021 CPT E/M codes. Of note, there will be modest payment increases for most office E/M codes beginning Jan. 1, 2021, which may benefit those who manage patients with complex conditions.

In sum, what are the 2021 E/M changes

While there will be many changes to office/outpatient E/M visits, the most significant are deletion of code 99201 (Level 1 new patient visit), addition of a 15-minute prolonged services code that can be reported with 99205 and 99215, and the following restructuring of office visit code selection:

1. Elimination of history and physical as elements for code selection: While obtaining a pertinent history and performing a relevant physical exam are clinically necessary and contribute to both time and medical decision making, these elements will not factor in to code selection. Instead, the code level will be determined solely by medical decision making or time.

2. Choice of using medical decision making (MDM) or total time as the basis of E/M level documentation:

• MDM. While there will still be three MDM subcomponents (number/complexity of problems, data, and risk), extensive edits were made to the ways in which these elements are defined and tallied.
• Time. The definition of time is now minimum time, not typical time or “face-to-face” time. Minimum time represents total physician/qualified health care professional time on the date of service. This redefinition of time allows Medicare to better recognize the work involved in non–face-to-face services like care coordination and record review. Of note, these definitions only apply when code selection is based on time and not MDM.

3. Modification of the criteria for MDM: The current CMS Table of Risk was used as a foundation for designing the revised required elements for MDM.

• Terms. Removed ambiguous terms (e.g., “mild”) and defined previously ambiguous concepts (e.g., “acute or chronic illness with systemic symptoms”).
• Definitions. Defined important terms, such as “independent historian.”
• Data elements. Re-defined the data elements to move away from simply adding up tasks to focusing on how those tasks affect the management of the patient (e.g., independent interpretation of a test performed by another provider and/or discussion of test interpretation with another physician).

CMS also plans to add a new Healthcare Common Procedure Coding System (HCPCS) add-on code as of Jan. 1, 2021, that can be used to recognize additional resource costs that are inherent in treating complex patients.

• GPCX1 - Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex chronic condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established.).

GPC1X can be reported with all levels of E/M office/outpatient codes in which care of a patient’s single, serious, or complex chronic condition is the focus. CMS plans to reimburse GPC1X at 0.33 RVUs (about $12).
 

Who do these changes apply to?

The changes to the E/M office/outpatient CPT codes and guidelines for new and established patients apply to all traditional Medicare and Medicare Advantage plans, Medicaid, and all commercial payers. E/M HCPCS codes apply to Medicare, Medicare Advantage plans, and Medicaid only; commercial payers are not required to accept HCPCS codes.

What should you do?

Visit the AMA E/M Microsite; there you will find the AMA’s early release of the 2021 E/M coding and guideline changes, the AMA E/M learning module and future resources on the use of time and MDM that are expected to be released in March.

AMA E/M Microsite: https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management

2021 E/M changes: https://www.ama-assn.org/system/files/2019-06/cpt-office-prolonged-svs-code-changes.pdf

AMA E/M learning module: https://edhub.ama-assn.org/interactive/18057429

AMA MDM table: https://www.ama-assn.org/system/files/2019-06/cpt-revised-mdm-grid.pdf

Connect with your coders and/or medical billing company to create a plan for training physicians and staff to ensure a smooth transition on Jan. 1, 2021.

Contact your Electronic Health Records (EHR) vendor to confirm the system your practice uses will be ready to implement the new E/M coding and guidelines changes on Jan. 1, 2021.

Run an analysis using the new E/M office/outpatient payment rates recommended by the AMA for 2021 (https://www.ama-assn.org/about/rvs-update-committee-ruc/ruc-recommendations-minutes-voting) for each of your practice’s contracted payers to determine if your practice will benefit from the new rates. While CMS has proposed to accept the AMA recommended rates, this will not be finalized until CMS publishes the 2021 proposed rule in early July 2020.

Once CMS confirms its decision, reach out to your payers to negotiate implementing the new E/M rates starting in 2021.

With changes this big, we encourage you to prepare early. Watch for more information on the 2021 E/M changes in Washington Insider and AGA eDigest.
 

Dr. Kuo is the AGA’s Advisor to the AMA CPT Editorial Panel and a member of the AGA Practice Management and Economics Committee’s (PMEC) Coverage and Reimbursement Subcommittee (CRS) and assistant professor of medicine and gastroenterology, Harvard Medical School and Massachusetts General Hospital, Boston; Dr. Losurdo is the AGA’s Alternate Advisor to the AMA CPT Editorial Panel, a member of the AGA PMEC’s CRS, and Managing Partner and medical director of Illinois Gastroenterology Group, Elgin, Ill.; Dr. Mehta is the AGA’s advisor to the AMA RVS Update Committee (RUC), a member of the AGA PMEC’s CRS, and assistant professor of medicine at the University of Pennsylvania, Philadelphia; and Dr. Garcia is the AGA’s Alternate Advisor to the AMA RUC, a member of the AGA PMEC’s CRS, and assistant professor of medicine and gastroenterology at Stanford (Calif.) University. There were no conflicts of interest.

Cancer patients in states that opted to expand Medicaid insurance coverage under the Affordable Care Act saw a slightly better rate of early diagnosis, compared with patients in states that refused expansion, according to a new study. However, time to treatment was similar in states that opted for expansion and states that did not.

Samuel U. Takvorian, MD, of the University of Pennsylvania, Philadelphia, and colleagues reported these results in JAMA Network Open.

The researchers used the National Cancer Database to examine the changes in health insurance coverage and cancer health outcomes in nonelderly patients following implementation of the Affordable Care Act in January 2014. The investigators identified records for 925,543 patients who had new-onset breast (59%), colon (15%), or non–small cell lung (27%) cancer between 2011 and 2016. The patients’ mean age was 55 years (range, 40-64 years), 79% were women, 14% were black, and 6% were Hispanic.

The researchers looked at insurance status, cancer stage at diagnosis, and treatment initiation within 30 and 90 days of diagnosis. The cohort was equally divided between residents of Medicaid expansion states (48%) and nonexpansion states (52%).

Using a statistical technique that mimics a controlled experiment, the investigators found the percentage of uninsured patients decreased more in the expansion states (adjusted difference-in-differences, −0.7 percentage points; 95% confidence interval, −1.2 to −0.3; P = .001), compared with nonexpansion states. Expansion states also had a greater increase in early-stage cancer diagnoses (adjusted DID, 0.8; 95% CI 0.3-1.2; P = .001) and a greater decrease in advanced-stage cancer diagnoses (adjusted DID, −0.5; 95% CI, −0.9 to −0.2; P = .003).

Among the 848,329 patients who underwent cancer treatment within a year of diagnosis, the percentage initiating treatment within 30 days declined from 52.7% before to 48% after Medicaid expansion in states opting in (unadjusted DID, −4.7; percentage points, 95% CI; −5.1 to −4.5). States that did not expand their Medicaid programs, meanwhile, saw the share decline from 56.9% to 51.5% in the same time period (adjusted DID, −5.4; 95% CI, −5.6 to −5.1). There was no statistically significant difference in timely treatment associated with Medicaid expansion (adjusted DID, 0.6; 95% CI, −0.2 to 1.4; P = .14).

The researchers speculated that the lack of significant between-group differences in time to treatment, despite an improvement in early-stage diagnoses associated with Medicaid expansion, could reflect a cancer care system strained by a surge in insured patients, overall increases in cancer prevalence and complexity of care, a shortage of workers, or a mixture of factors.

In a related editorial, Sue Fu, MD, of Stanford (Calif.) University, and colleagues wrote that, while the findings of increased early diagnosis seen in the study are promising, the time to treatment results are “puzzling” and deserve further consideration.

Time to treatment is important in cancer, as longer times are associated with increased mortality, Dr. Fu and colleagues noted. Slowing times to cancer treatment is a systemic problem in the United States that has been documented since the mid-2000s. Paradoxically, expanded insurance coverage could contribute to increasing time to treatment even after timely diagnosis by adding administrative burdens leading to longer wait times. “Newly insured and underinsured individuals may be particularly vulnerable to this,” the editorialists wrote.

Dr. Takvorian and colleagues noted as weaknesses of their study its observational design, a limited range of ages and cancers included, and an inability to adjust for state-level effects.

This study was funded by the National Cancer Institute and the Agency for Health Research and Quality. The authors of the study and the editorial disclosed no relevant conflicts of interest.

SOURCES: Takvorian SU et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921653; Fu S et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921690.

Cancer patients in states that opted to expand Medicaid insurance coverage under the Affordable Care Act saw a slightly better rate of early diagnosis, compared with patients in states that refused expansion, according to a new study. However, time to treatment was similar in states that opted for expansion and states that did not.

Samuel U. Takvorian, MD, of the University of Pennsylvania, Philadelphia, and colleagues reported these results in JAMA Network Open.

The researchers used the National Cancer Database to examine the changes in health insurance coverage and cancer health outcomes in nonelderly patients following implementation of the Affordable Care Act in January 2014. The investigators identified records for 925,543 patients who had new-onset breast (59%), colon (15%), or non–small cell lung (27%) cancer between 2011 and 2016. The patients’ mean age was 55 years (range, 40-64 years), 79% were women, 14% were black, and 6% were Hispanic.

The researchers looked at insurance status, cancer stage at diagnosis, and treatment initiation within 30 and 90 days of diagnosis. The cohort was equally divided between residents of Medicaid expansion states (48%) and nonexpansion states (52%).

Using a statistical technique that mimics a controlled experiment, the investigators found the percentage of uninsured patients decreased more in the expansion states (adjusted difference-in-differences, −0.7 percentage points; 95% confidence interval, −1.2 to −0.3; P = .001), compared with nonexpansion states. Expansion states also had a greater increase in early-stage cancer diagnoses (adjusted DID, 0.8; 95% CI 0.3-1.2; P = .001) and a greater decrease in advanced-stage cancer diagnoses (adjusted DID, −0.5; 95% CI, −0.9 to −0.2; P = .003).

Among the 848,329 patients who underwent cancer treatment within a year of diagnosis, the percentage initiating treatment within 30 days declined from 52.7% before to 48% after Medicaid expansion in states opting in (unadjusted DID, −4.7; percentage points, 95% CI; −5.1 to −4.5). States that did not expand their Medicaid programs, meanwhile, saw the share decline from 56.9% to 51.5% in the same time period (adjusted DID, −5.4; 95% CI, −5.6 to −5.1). There was no statistically significant difference in timely treatment associated with Medicaid expansion (adjusted DID, 0.6; 95% CI, −0.2 to 1.4; P = .14).

The researchers speculated that the lack of significant between-group differences in time to treatment, despite an improvement in early-stage diagnoses associated with Medicaid expansion, could reflect a cancer care system strained by a surge in insured patients, overall increases in cancer prevalence and complexity of care, a shortage of workers, or a mixture of factors.

In a related editorial, Sue Fu, MD, of Stanford (Calif.) University, and colleagues wrote that, while the findings of increased early diagnosis seen in the study are promising, the time to treatment results are “puzzling” and deserve further consideration.

Time to treatment is important in cancer, as longer times are associated with increased mortality, Dr. Fu and colleagues noted. Slowing times to cancer treatment is a systemic problem in the United States that has been documented since the mid-2000s. Paradoxically, expanded insurance coverage could contribute to increasing time to treatment even after timely diagnosis by adding administrative burdens leading to longer wait times. “Newly insured and underinsured individuals may be particularly vulnerable to this,” the editorialists wrote.

Dr. Takvorian and colleagues noted as weaknesses of their study its observational design, a limited range of ages and cancers included, and an inability to adjust for state-level effects.

This study was funded by the National Cancer Institute and the Agency for Health Research and Quality. The authors of the study and the editorial disclosed no relevant conflicts of interest.

SOURCES: Takvorian SU et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921653; Fu S et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921690.

Cancer patients in states that opted to expand Medicaid insurance coverage under the Affordable Care Act saw a slightly better rate of early diagnosis, compared with patients in states that refused expansion, according to a new study. However, time to treatment was similar in states that opted for expansion and states that did not.

Samuel U. Takvorian, MD, of the University of Pennsylvania, Philadelphia, and colleagues reported these results in JAMA Network Open.

The researchers used the National Cancer Database to examine the changes in health insurance coverage and cancer health outcomes in nonelderly patients following implementation of the Affordable Care Act in January 2014. The investigators identified records for 925,543 patients who had new-onset breast (59%), colon (15%), or non–small cell lung (27%) cancer between 2011 and 2016. The patients’ mean age was 55 years (range, 40-64 years), 79% were women, 14% were black, and 6% were Hispanic.

The researchers looked at insurance status, cancer stage at diagnosis, and treatment initiation within 30 and 90 days of diagnosis. The cohort was equally divided between residents of Medicaid expansion states (48%) and nonexpansion states (52%).

Using a statistical technique that mimics a controlled experiment, the investigators found the percentage of uninsured patients decreased more in the expansion states (adjusted difference-in-differences, −0.7 percentage points; 95% confidence interval, −1.2 to −0.3; P = .001), compared with nonexpansion states. Expansion states also had a greater increase in early-stage cancer diagnoses (adjusted DID, 0.8; 95% CI 0.3-1.2; P = .001) and a greater decrease in advanced-stage cancer diagnoses (adjusted DID, −0.5; 95% CI, −0.9 to −0.2; P = .003).

Among the 848,329 patients who underwent cancer treatment within a year of diagnosis, the percentage initiating treatment within 30 days declined from 52.7% before to 48% after Medicaid expansion in states opting in (unadjusted DID, −4.7; percentage points, 95% CI; −5.1 to −4.5). States that did not expand their Medicaid programs, meanwhile, saw the share decline from 56.9% to 51.5% in the same time period (adjusted DID, −5.4; 95% CI, −5.6 to −5.1). There was no statistically significant difference in timely treatment associated with Medicaid expansion (adjusted DID, 0.6; 95% CI, −0.2 to 1.4; P = .14).

The researchers speculated that the lack of significant between-group differences in time to treatment, despite an improvement in early-stage diagnoses associated with Medicaid expansion, could reflect a cancer care system strained by a surge in insured patients, overall increases in cancer prevalence and complexity of care, a shortage of workers, or a mixture of factors.

In a related editorial, Sue Fu, MD, of Stanford (Calif.) University, and colleagues wrote that, while the findings of increased early diagnosis seen in the study are promising, the time to treatment results are “puzzling” and deserve further consideration.

Time to treatment is important in cancer, as longer times are associated with increased mortality, Dr. Fu and colleagues noted. Slowing times to cancer treatment is a systemic problem in the United States that has been documented since the mid-2000s. Paradoxically, expanded insurance coverage could contribute to increasing time to treatment even after timely diagnosis by adding administrative burdens leading to longer wait times. “Newly insured and underinsured individuals may be particularly vulnerable to this,” the editorialists wrote.

Dr. Takvorian and colleagues noted as weaknesses of their study its observational design, a limited range of ages and cancers included, and an inability to adjust for state-level effects.

This study was funded by the National Cancer Institute and the Agency for Health Research and Quality. The authors of the study and the editorial disclosed no relevant conflicts of interest.

SOURCES: Takvorian SU et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921653; Fu S et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921690.

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. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Adherence to noninvasive CRC screening (http://ow.ly/6eng30qfUKq)

2. Q&A with Guideline authors: Management of gastric intestinal metaplasia (GIM) (http://ow.ly/Cxsl30qfUYm).

3. IBD patient: Crohn’s colitis (http://ow.ly/DsOg30qfUNt).

4. Patient with intractable abdominal pain (http://ow.ly/EPFi30qfUsi).

5. IBD patient: Ulcerative colitis (http://ow.ly/d6e730qfUVZ).

Access these clinical cases and more discussions 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. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Adherence to noninvasive CRC screening (http://ow.ly/6eng30qfUKq)

2. Q&A with Guideline authors: Management of gastric intestinal metaplasia (GIM) (http://ow.ly/Cxsl30qfUYm).

3. IBD patient: Crohn’s colitis (http://ow.ly/DsOg30qfUNt).

4. Patient with intractable abdominal pain (http://ow.ly/EPFi30qfUsi).

5. IBD patient: Ulcerative colitis (http://ow.ly/d6e730qfUVZ).

Access these clinical cases and more discussions 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. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Adherence to noninvasive CRC screening (http://ow.ly/6eng30qfUKq)

2. Q&A with Guideline authors: Management of gastric intestinal metaplasia (GIM) (http://ow.ly/Cxsl30qfUYm).

3. IBD patient: Crohn’s colitis (http://ow.ly/DsOg30qfUNt).

4. Patient with intractable abdominal pain (http://ow.ly/EPFi30qfUsi).

5. IBD patient: Ulcerative colitis (http://ow.ly/d6e730qfUVZ).

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Five serum markers detect systemic inflammation in patients with psoriatic disease in the absence of elevated C-reactive protein, according to a cross-sectional study of patients and healthy controls.

“Different clinical subsets of psoriatic disease based on skin, entheseal, and joint involvement are characterized by specific inflammation marker profiles,” Maria V. Sokolova, MD, of Friedrich-Alexander University Erlangen-Nuremberg and University Clinic Erlangen (Germany) and colleagues reported in Arthritis Research & Therapy. “Treatment of psoriatic disease with cytokine inhibitors reduces these elevated levels of systemic inflammation markers.”

Quantifying systemic inflammation in psoriatic disease has been a challenge, Dr. Sokolova and colleagues wrote. Levels of C-reactive protein (CRP), a commonly used measure of systemic inflammation, “are often low or absent.” To examine other potential markers of systemic inflammation in psoriatic disease, the investigators conducted cross-sectional and longitudinal studies that included healthy controls and patients with psoriatic disease. Patients had isolated or combined manifestations of psoriatic disease, including the skin, the entheses, and the joints. The researchers grouped patients by isolated psoriatic skin disease; isolated enthesitis; isolated arthritis; psoriatic skin disease with enthesitis; psoriatic skin disease with arthritis; arthritis and enthesitis; and combined psoriatic skin disease, arthritis, and enthesitis.
 

Data from more than 100 patients

The researchers first assessed 10 potential markers using enzyme-linked immunosorbent assay: calprotectin, interleukin-22, IL-8, lipocalin 2, beta-defensin 2, IL-17, IL-23, vascular endothelial growth factors, LL37 (cathelicidin), and pentraxin 3. They measured the markers in 10 healthy controls and 10 patients with active polymorphic psoriatic arthritis. Five parameters – beta-defensin 2, lipocalin 2, IL-22, IL-8, and calprotectin – significantly differed between healthy controls and patients with psoriatic disease. Lipocalin 2, beta-defensin 2, and IL-22 are associated with IL-17/IL-23 activation, and calprotectin and IL-8 are associated with innate immune cell activation. The other markers did not significantly differ or were not detectable in enough participants.

To validate the signals, the researchers measured the five parameters as well as CRP in 105 controls and 105 patients with psoriatic disease, including 15 patients in each of the seven disease pattern groups. “As expected, CRP levels were normal in the majority of individuals,” the authors wrote. The proportion of patients with CRP greater than 5 mg/L was 0% in isolated psoriatic skin disease, 0% in isolated enthesitis; 20% in isolated arthritis; 7% in psoriatic skin disease with enthesitis; 33% in psoriatic skin disease with arthritis; 27% in arthritis with enthesitis; and 33% in combined psoriatic skin disease, arthritis, and enthesitis.

“Only a subset of patients with arthritis, but not patients with skin or entheseal disease show elevated CRP,” the researchers wrote. “In sharp contrast,” beta-defensin 2 and lipocalin 2 were elevated in a majority of patients with monomorphic skin and entheseal disease, but not in joint disease. “Both proteins were significantly correlated to the extent of skin disease and to a lesser extent also entheseal disease,” they added. Calprotectin and IL-8 were elevated in a majority of patients with joint disease and correlated with the extent of arthritis. “IL-22 was elevated ... in all three manifestations of psoriatic disease,” and the vast majority of patients with polymorphic disease had “widespread marker elevation,” the researchers wrote.
 

Effects of treatment

In a study of 20 patients with psoriatic arthritis, treatment with secukinumab or adalimumab significantly lowered all five markers. Compared with tumor necrosis factor inhibition with adalimumab, “IL-17 inhibition [with secukinumab] showed a more pronounced lowering of lipocalin 2 and beta-defensin 2 levels,” the investigators noted.

“These results confirm earlier data showing elevated beta-defensin levels in psoriasis patients and its association with the extent of skin involvement,” Dr. Sokolova and colleagues wrote. “Overall, these results offer a new possibility to measure systemic inflammation in psoriatic disease.”

The study was supported by the German Research Foundation and other grant and fellowship funding. The authors had no competing interests.

jremaly@mdedge.com

SOURCE: Sokolova MV et al. Arthritis Res Ther. 2020;22:26.

Five serum markers detect systemic inflammation in patients with psoriatic disease in the absence of elevated C-reactive protein, according to a cross-sectional study of patients and healthy controls.

“Different clinical subsets of psoriatic disease based on skin, entheseal, and joint involvement are characterized by specific inflammation marker profiles,” Maria V. Sokolova, MD, of Friedrich-Alexander University Erlangen-Nuremberg and University Clinic Erlangen (Germany) and colleagues reported in Arthritis Research & Therapy. “Treatment of psoriatic disease with cytokine inhibitors reduces these elevated levels of systemic inflammation markers.”

Quantifying systemic inflammation in psoriatic disease has been a challenge, Dr. Sokolova and colleagues wrote. Levels of C-reactive protein (CRP), a commonly used measure of systemic inflammation, “are often low or absent.” To examine other potential markers of systemic inflammation in psoriatic disease, the investigators conducted cross-sectional and longitudinal studies that included healthy controls and patients with psoriatic disease. Patients had isolated or combined manifestations of psoriatic disease, including the skin, the entheses, and the joints. The researchers grouped patients by isolated psoriatic skin disease; isolated enthesitis; isolated arthritis; psoriatic skin disease with enthesitis; psoriatic skin disease with arthritis; arthritis and enthesitis; and combined psoriatic skin disease, arthritis, and enthesitis.
 

Data from more than 100 patients

The researchers first assessed 10 potential markers using enzyme-linked immunosorbent assay: calprotectin, interleukin-22, IL-8, lipocalin 2, beta-defensin 2, IL-17, IL-23, vascular endothelial growth factors, LL37 (cathelicidin), and pentraxin 3. They measured the markers in 10 healthy controls and 10 patients with active polymorphic psoriatic arthritis. Five parameters – beta-defensin 2, lipocalin 2, IL-22, IL-8, and calprotectin – significantly differed between healthy controls and patients with psoriatic disease. Lipocalin 2, beta-defensin 2, and IL-22 are associated with IL-17/IL-23 activation, and calprotectin and IL-8 are associated with innate immune cell activation. The other markers did not significantly differ or were not detectable in enough participants.

To validate the signals, the researchers measured the five parameters as well as CRP in 105 controls and 105 patients with psoriatic disease, including 15 patients in each of the seven disease pattern groups. “As expected, CRP levels were normal in the majority of individuals,” the authors wrote. The proportion of patients with CRP greater than 5 mg/L was 0% in isolated psoriatic skin disease, 0% in isolated enthesitis; 20% in isolated arthritis; 7% in psoriatic skin disease with enthesitis; 33% in psoriatic skin disease with arthritis; 27% in arthritis with enthesitis; and 33% in combined psoriatic skin disease, arthritis, and enthesitis.

“Only a subset of patients with arthritis, but not patients with skin or entheseal disease show elevated CRP,” the researchers wrote. “In sharp contrast,” beta-defensin 2 and lipocalin 2 were elevated in a majority of patients with monomorphic skin and entheseal disease, but not in joint disease. “Both proteins were significantly correlated to the extent of skin disease and to a lesser extent also entheseal disease,” they added. Calprotectin and IL-8 were elevated in a majority of patients with joint disease and correlated with the extent of arthritis. “IL-22 was elevated ... in all three manifestations of psoriatic disease,” and the vast majority of patients with polymorphic disease had “widespread marker elevation,” the researchers wrote.
 

Effects of treatment

In a study of 20 patients with psoriatic arthritis, treatment with secukinumab or adalimumab significantly lowered all five markers. Compared with tumor necrosis factor inhibition with adalimumab, “IL-17 inhibition [with secukinumab] showed a more pronounced lowering of lipocalin 2 and beta-defensin 2 levels,” the investigators noted.

“These results confirm earlier data showing elevated beta-defensin levels in psoriasis patients and its association with the extent of skin involvement,” Dr. Sokolova and colleagues wrote. “Overall, these results offer a new possibility to measure systemic inflammation in psoriatic disease.”

The study was supported by the German Research Foundation and other grant and fellowship funding. The authors had no competing interests.

jremaly@mdedge.com

SOURCE: Sokolova MV et al. Arthritis Res Ther. 2020;22:26.

Five serum markers detect systemic inflammation in patients with psoriatic disease in the absence of elevated C-reactive protein, according to a cross-sectional study of patients and healthy controls.

“Different clinical subsets of psoriatic disease based on skin, entheseal, and joint involvement are characterized by specific inflammation marker profiles,” Maria V. Sokolova, MD, of Friedrich-Alexander University Erlangen-Nuremberg and University Clinic Erlangen (Germany) and colleagues reported in Arthritis Research & Therapy. “Treatment of psoriatic disease with cytokine inhibitors reduces these elevated levels of systemic inflammation markers.”

Quantifying systemic inflammation in psoriatic disease has been a challenge, Dr. Sokolova and colleagues wrote. Levels of C-reactive protein (CRP), a commonly used measure of systemic inflammation, “are often low or absent.” To examine other potential markers of systemic inflammation in psoriatic disease, the investigators conducted cross-sectional and longitudinal studies that included healthy controls and patients with psoriatic disease. Patients had isolated or combined manifestations of psoriatic disease, including the skin, the entheses, and the joints. The researchers grouped patients by isolated psoriatic skin disease; isolated enthesitis; isolated arthritis; psoriatic skin disease with enthesitis; psoriatic skin disease with arthritis; arthritis and enthesitis; and combined psoriatic skin disease, arthritis, and enthesitis.
 

Data from more than 100 patients

The researchers first assessed 10 potential markers using enzyme-linked immunosorbent assay: calprotectin, interleukin-22, IL-8, lipocalin 2, beta-defensin 2, IL-17, IL-23, vascular endothelial growth factors, LL37 (cathelicidin), and pentraxin 3. They measured the markers in 10 healthy controls and 10 patients with active polymorphic psoriatic arthritis. Five parameters – beta-defensin 2, lipocalin 2, IL-22, IL-8, and calprotectin – significantly differed between healthy controls and patients with psoriatic disease. Lipocalin 2, beta-defensin 2, and IL-22 are associated with IL-17/IL-23 activation, and calprotectin and IL-8 are associated with innate immune cell activation. The other markers did not significantly differ or were not detectable in enough participants.

To validate the signals, the researchers measured the five parameters as well as CRP in 105 controls and 105 patients with psoriatic disease, including 15 patients in each of the seven disease pattern groups. “As expected, CRP levels were normal in the majority of individuals,” the authors wrote. The proportion of patients with CRP greater than 5 mg/L was 0% in isolated psoriatic skin disease, 0% in isolated enthesitis; 20% in isolated arthritis; 7% in psoriatic skin disease with enthesitis; 33% in psoriatic skin disease with arthritis; 27% in arthritis with enthesitis; and 33% in combined psoriatic skin disease, arthritis, and enthesitis.

“Only a subset of patients with arthritis, but not patients with skin or entheseal disease show elevated CRP,” the researchers wrote. “In sharp contrast,” beta-defensin 2 and lipocalin 2 were elevated in a majority of patients with monomorphic skin and entheseal disease, but not in joint disease. “Both proteins were significantly correlated to the extent of skin disease and to a lesser extent also entheseal disease,” they added. Calprotectin and IL-8 were elevated in a majority of patients with joint disease and correlated with the extent of arthritis. “IL-22 was elevated ... in all three manifestations of psoriatic disease,” and the vast majority of patients with polymorphic disease had “widespread marker elevation,” the researchers wrote.
 

Effects of treatment

In a study of 20 patients with psoriatic arthritis, treatment with secukinumab or adalimumab significantly lowered all five markers. Compared with tumor necrosis factor inhibition with adalimumab, “IL-17 inhibition [with secukinumab] showed a more pronounced lowering of lipocalin 2 and beta-defensin 2 levels,” the investigators noted.

“These results confirm earlier data showing elevated beta-defensin levels in psoriasis patients and its association with the extent of skin involvement,” Dr. Sokolova and colleagues wrote. “Overall, these results offer a new possibility to measure systemic inflammation in psoriatic disease.”

The study was supported by the German Research Foundation and other grant and fellowship funding. The authors had no competing interests.

jremaly@mdedge.com

SOURCE: Sokolova MV et al. Arthritis Res Ther. 2020;22:26.

LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

“If somebody is trying to start a practice in lesional teledermatology, I would recommend getting dermoscopy images with all of the teledermatology consults. The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.

To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.

“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.

Why get into teledermatology?

The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).

In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.

“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.

Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
 

Before getting started

Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.

The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.

The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)

Teledermatology practice model options

The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.

The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.

“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.

Reimbursement

Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.

Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.

“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.

And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
 

How accurate is teledermatology?

Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.

In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”

“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.

He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.

Dr. Tejasvi reported having no financial conflicts regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

“If somebody is trying to start a practice in lesional teledermatology, I would recommend getting dermoscopy images with all of the teledermatology consults. The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.

To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.

“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.

Why get into teledermatology?

The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).

In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.

“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.

Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
 

Before getting started

Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.

The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.

The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)

Teledermatology practice model options

The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.

The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.

“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.

Reimbursement

Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.

Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.

“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.

And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
 

How accurate is teledermatology?

Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.

In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”

“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.

He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.

Dr. Tejasvi reported having no financial conflicts regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

“If somebody is trying to start a practice in lesional teledermatology, I would recommend getting dermoscopy images with all of the teledermatology consults. The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.

To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.

“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.

Why get into teledermatology?

The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).

In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.

“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.

Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
 

Before getting started

Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.

The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.

The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)

Teledermatology practice model options

The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.

The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.

“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.

Reimbursement

Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.

Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.

“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.

And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
 

How accurate is teledermatology?

Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.

In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”

“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.

He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.

Dr. Tejasvi reported having no financial conflicts regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

A treatment commonly used as a salvage regimen for relapsed/refractory acute myelogenous leukemia (AML) showed better results than did standard treatment when used as initial induction therapy.

Researchers found that the use of fludarabine, high-dose cytarabine, with granulocyte-colony stimulating factor (FLAG) – with or without idarubicin (Ida) – resulted in higher remission rates for nonfavorable risk AML patients after one course of induction, compared with standard 7+3 (anthracycline plus cytarabine) treatment.

The use of FLAG+/-Ida also resulted in a shorter time to complete remission (CR) and a shorter time to transplant, compared with 7+3. Additionally, postremission overall survival (OS) and disease-free survival (DFS) were better after achieving CR from FLAG-Ida, compared with 7+3, Melhem Solh, MD, of the Blood & Marrow Transplant Program at Northside Hospital, Atlanta, and colleagues reported in Leukemia Research.

The researchers retrospectively analyzed 304 consecutive AML patients, with nonfavorable National Comprehensive Cancer Network (NCCN) risk who received initial treatment at their center with either 7+3 (86 patients) or FLAG+/-Ida (218 patients). They found that patients in the FLAG+/-Ida group were more likely to achieve remission after one course of induction (74% vs. 62%; P less than .001) and had a faster time to achieve CR (30 days vs. 37.5 days; P less than .001), compared with patients receiving 7+3.

The time from diagnosis to allogeneic hematopoietic cell transplantation was shorter among CR patients after FLAG+/-Ida, compared with 7+3 (115 days vs. 151 days; P less than .003).

Additionally, the 3-year postremission OS and DFS were significantly better for patients receiving FLAG-Ida at 54% and 49%, compared with 39% and 32% for 7+3, respectively (P = .01).

Dr. Solh and colleagues found that the factors associated with postremission survival included age at first CR, NCCN risk, induction regimen (FLAG+/-Ida vs. 7+3; hazard ratio, 0.62; P = .01), and receipt of allogeneic hematopoietic cell transplantation.

“FLAG-Ida is a more efficacious regimen when used for initial induction compared to 3+7. It appears to produce better survival and improved postremission survival for AML patients with intermediate and poor risk AML without increasing toxicity,” Dr. Solh and colleagues wrote. “Further validation of these results in a well-designed randomized prospective trial will help define the best induction approaches for AML.”

There was no outside funding for this research and the authors reported that they had no relevant financial conflicts.

mlesney@mdedge.com

SOURCE: Solh MM et al. Leuk Res. 2020 Feb 14. doi: 10.1016/j.leukres.2020.106318.

A treatment commonly used as a salvage regimen for relapsed/refractory acute myelogenous leukemia (AML) showed better results than did standard treatment when used as initial induction therapy.

Researchers found that the use of fludarabine, high-dose cytarabine, with granulocyte-colony stimulating factor (FLAG) – with or without idarubicin (Ida) – resulted in higher remission rates for nonfavorable risk AML patients after one course of induction, compared with standard 7+3 (anthracycline plus cytarabine) treatment.

The use of FLAG+/-Ida also resulted in a shorter time to complete remission (CR) and a shorter time to transplant, compared with 7+3. Additionally, postremission overall survival (OS) and disease-free survival (DFS) were better after achieving CR from FLAG-Ida, compared with 7+3, Melhem Solh, MD, of the Blood & Marrow Transplant Program at Northside Hospital, Atlanta, and colleagues reported in Leukemia Research.

The researchers retrospectively analyzed 304 consecutive AML patients, with nonfavorable National Comprehensive Cancer Network (NCCN) risk who received initial treatment at their center with either 7+3 (86 patients) or FLAG+/-Ida (218 patients). They found that patients in the FLAG+/-Ida group were more likely to achieve remission after one course of induction (74% vs. 62%; P less than .001) and had a faster time to achieve CR (30 days vs. 37.5 days; P less than .001), compared with patients receiving 7+3.

The time from diagnosis to allogeneic hematopoietic cell transplantation was shorter among CR patients after FLAG+/-Ida, compared with 7+3 (115 days vs. 151 days; P less than .003).

Additionally, the 3-year postremission OS and DFS were significantly better for patients receiving FLAG-Ida at 54% and 49%, compared with 39% and 32% for 7+3, respectively (P = .01).

Dr. Solh and colleagues found that the factors associated with postremission survival included age at first CR, NCCN risk, induction regimen (FLAG+/-Ida vs. 7+3; hazard ratio, 0.62; P = .01), and receipt of allogeneic hematopoietic cell transplantation.

“FLAG-Ida is a more efficacious regimen when used for initial induction compared to 3+7. It appears to produce better survival and improved postremission survival for AML patients with intermediate and poor risk AML without increasing toxicity,” Dr. Solh and colleagues wrote. “Further validation of these results in a well-designed randomized prospective trial will help define the best induction approaches for AML.”

There was no outside funding for this research and the authors reported that they had no relevant financial conflicts.

mlesney@mdedge.com

SOURCE: Solh MM et al. Leuk Res. 2020 Feb 14. doi: 10.1016/j.leukres.2020.106318.

A treatment commonly used as a salvage regimen for relapsed/refractory acute myelogenous leukemia (AML) showed better results than did standard treatment when used as initial induction therapy.

Researchers found that the use of fludarabine, high-dose cytarabine, with granulocyte-colony stimulating factor (FLAG) – with or without idarubicin (Ida) – resulted in higher remission rates for nonfavorable risk AML patients after one course of induction, compared with standard 7+3 (anthracycline plus cytarabine) treatment.

The use of FLAG+/-Ida also resulted in a shorter time to complete remission (CR) and a shorter time to transplant, compared with 7+3. Additionally, postremission overall survival (OS) and disease-free survival (DFS) were better after achieving CR from FLAG-Ida, compared with 7+3, Melhem Solh, MD, of the Blood & Marrow Transplant Program at Northside Hospital, Atlanta, and colleagues reported in Leukemia Research.

The researchers retrospectively analyzed 304 consecutive AML patients, with nonfavorable National Comprehensive Cancer Network (NCCN) risk who received initial treatment at their center with either 7+3 (86 patients) or FLAG+/-Ida (218 patients). They found that patients in the FLAG+/-Ida group were more likely to achieve remission after one course of induction (74% vs. 62%; P less than .001) and had a faster time to achieve CR (30 days vs. 37.5 days; P less than .001), compared with patients receiving 7+3.

The time from diagnosis to allogeneic hematopoietic cell transplantation was shorter among CR patients after FLAG+/-Ida, compared with 7+3 (115 days vs. 151 days; P less than .003).

Additionally, the 3-year postremission OS and DFS were significantly better for patients receiving FLAG-Ida at 54% and 49%, compared with 39% and 32% for 7+3, respectively (P = .01).

Dr. Solh and colleagues found that the factors associated with postremission survival included age at first CR, NCCN risk, induction regimen (FLAG+/-Ida vs. 7+3; hazard ratio, 0.62; P = .01), and receipt of allogeneic hematopoietic cell transplantation.

“FLAG-Ida is a more efficacious regimen when used for initial induction compared to 3+7. It appears to produce better survival and improved postremission survival for AML patients with intermediate and poor risk AML without increasing toxicity,” Dr. Solh and colleagues wrote. “Further validation of these results in a well-designed randomized prospective trial will help define the best induction approaches for AML.”

There was no outside funding for this research and the authors reported that they had no relevant financial conflicts.

mlesney@mdedge.com

SOURCE: Solh MM et al. Leuk Res. 2020 Feb 14. doi: 10.1016/j.leukres.2020.106318.

The Sidney Kimmel Cancer Center–Jefferson Health (SKCC) has a new director of bone marrow transplant and cell-based therapy, Mount Sinai has a new head of clinical cancer research, and the National Hemophilia Foundation (NHF) has a new president and CEO.

Usama Gergis, MD, has joined SKCC in Philadelphia as director of the bone marrow transplant and immune cellular therapy program and as a professor in the department of medical oncology, division of hematological malignancies.

Dr. Gergis came to SKCC from Weill Cornell Medicine in New York, where he helped expand the use of umbilical cord blood transplant and established an immune cellular therapy program. He also established and led one of the largest oncology international medicine programs in the United States.

Dr. Gergis earned his medical degree from Cairo (Egypt) University. He completed an internal medicine residency and a hematology/oncology fellowship at the Brooklyn Hospital of Weill Cornell. He also completed a bone marrow transplant fellowship at the Moffitt Cancer Center in Tampa.

Karyn Aalami Goodman, MD, has been hired to lead clinical cancer research at Mount Sinai, New York. She is now the associate director for clinical research at the Tisch Cancer Institute and a professor and vice-chair for research and quality in the department of radiation oncology. In these roles, she will develop the infrastructure and resources to support clinical trials of cancer patients.

Dr. Goodman’s own research is focused on improving outcomes for patients with gastrointestinal malignancies. She has helped develop protocols combining radiation, chemotherapy, targeted agents, and immunotherapy.

Dr. Goodman earned her medical degree from Stanford (Calif.) University. She completed an internship in internal medicine at Stanford and residency training in radiation oncology at Memorial Sloan-Kettering Cancer Center in New York. She was previously associate director of clinical research at the University of Colorado Cancer Center in Aurora.

Leonard A. Valentino, MD, has assumed the role of president and CEO of the National Hemophilia Foundation in New York. In this role, Dr. Valentino will “work to advance the foundation’s mission of education, advocacy, and research,” according to the NHF.

Dr. Valentino previously held leadership roles at Spark Therapeutics, Shire, Baxalta, and Baxter Healthcare Corporation. Prior to that, he founded and led the Hemophilia and Thrombophilia Center at Rush University Medical Center in Chicago.

Dr. Valentino earned his undergraduate and medical degrees from Creighton University in Omaha, Neb. He completed his residency at the University of Illinois at Chicago and a fellowship in pediatric hematology-oncology at the University of California, Los Angeles .

jensmith@mdedge.com

The Sidney Kimmel Cancer Center–Jefferson Health (SKCC) has a new director of bone marrow transplant and cell-based therapy, Mount Sinai has a new head of clinical cancer research, and the National Hemophilia Foundation (NHF) has a new president and CEO.

Usama Gergis, MD, has joined SKCC in Philadelphia as director of the bone marrow transplant and immune cellular therapy program and as a professor in the department of medical oncology, division of hematological malignancies.

Dr. Gergis came to SKCC from Weill Cornell Medicine in New York, where he helped expand the use of umbilical cord blood transplant and established an immune cellular therapy program. He also established and led one of the largest oncology international medicine programs in the United States.

Dr. Gergis earned his medical degree from Cairo (Egypt) University. He completed an internal medicine residency and a hematology/oncology fellowship at the Brooklyn Hospital of Weill Cornell. He also completed a bone marrow transplant fellowship at the Moffitt Cancer Center in Tampa.

Karyn Aalami Goodman, MD, has been hired to lead clinical cancer research at Mount Sinai, New York. She is now the associate director for clinical research at the Tisch Cancer Institute and a professor and vice-chair for research and quality in the department of radiation oncology. In these roles, she will develop the infrastructure and resources to support clinical trials of cancer patients.

Dr. Goodman’s own research is focused on improving outcomes for patients with gastrointestinal malignancies. She has helped develop protocols combining radiation, chemotherapy, targeted agents, and immunotherapy.

Dr. Goodman earned her medical degree from Stanford (Calif.) University. She completed an internship in internal medicine at Stanford and residency training in radiation oncology at Memorial Sloan-Kettering Cancer Center in New York. She was previously associate director of clinical research at the University of Colorado Cancer Center in Aurora.

Leonard A. Valentino, MD, has assumed the role of president and CEO of the National Hemophilia Foundation in New York. In this role, Dr. Valentino will “work to advance the foundation’s mission of education, advocacy, and research,” according to the NHF.

Dr. Valentino previously held leadership roles at Spark Therapeutics, Shire, Baxalta, and Baxter Healthcare Corporation. Prior to that, he founded and led the Hemophilia and Thrombophilia Center at Rush University Medical Center in Chicago.

Dr. Valentino earned his undergraduate and medical degrees from Creighton University in Omaha, Neb. He completed his residency at the University of Illinois at Chicago and a fellowship in pediatric hematology-oncology at the University of California, Los Angeles .

jensmith@mdedge.com

The Sidney Kimmel Cancer Center–Jefferson Health (SKCC) has a new director of bone marrow transplant and cell-based therapy, Mount Sinai has a new head of clinical cancer research, and the National Hemophilia Foundation (NHF) has a new president and CEO.

Usama Gergis, MD, has joined SKCC in Philadelphia as director of the bone marrow transplant and immune cellular therapy program and as a professor in the department of medical oncology, division of hematological malignancies.

Dr. Gergis came to SKCC from Weill Cornell Medicine in New York, where he helped expand the use of umbilical cord blood transplant and established an immune cellular therapy program. He also established and led one of the largest oncology international medicine programs in the United States.

Dr. Gergis earned his medical degree from Cairo (Egypt) University. He completed an internal medicine residency and a hematology/oncology fellowship at the Brooklyn Hospital of Weill Cornell. He also completed a bone marrow transplant fellowship at the Moffitt Cancer Center in Tampa.

Karyn Aalami Goodman, MD, has been hired to lead clinical cancer research at Mount Sinai, New York. She is now the associate director for clinical research at the Tisch Cancer Institute and a professor and vice-chair for research and quality in the department of radiation oncology. In these roles, she will develop the infrastructure and resources to support clinical trials of cancer patients.

Dr. Goodman’s own research is focused on improving outcomes for patients with gastrointestinal malignancies. She has helped develop protocols combining radiation, chemotherapy, targeted agents, and immunotherapy.

Dr. Goodman earned her medical degree from Stanford (Calif.) University. She completed an internship in internal medicine at Stanford and residency training in radiation oncology at Memorial Sloan-Kettering Cancer Center in New York. She was previously associate director of clinical research at the University of Colorado Cancer Center in Aurora.

Leonard A. Valentino, MD, has assumed the role of president and CEO of the National Hemophilia Foundation in New York. In this role, Dr. Valentino will “work to advance the foundation’s mission of education, advocacy, and research,” according to the NHF.

Dr. Valentino previously held leadership roles at Spark Therapeutics, Shire, Baxalta, and Baxter Healthcare Corporation. Prior to that, he founded and led the Hemophilia and Thrombophilia Center at Rush University Medical Center in Chicago.

Dr. Valentino earned his undergraduate and medical degrees from Creighton University in Omaha, Neb. He completed his residency at the University of Illinois at Chicago and a fellowship in pediatric hematology-oncology at the University of California, Los Angeles .

jensmith@mdedge.com

NATIONAL HARBOR, MD. – Of characteristics that might predict which patients with resistant hypertension will respond to carotid body ablation, the relative activity of the carotid body organ itself might be critical for moving this technology forward, an investigator on a first-in-man study suggests.

The study, first presented in 2018 at the European Society of Cardiology congress, showed carotid body ablation resulted in significant but modest reductions in blood pressure in patients with resistant hypertension.

Ted Bosworth/MDedge News

For many reasons, the carotid body is an attractive target for sustained or indefinite control of resistant hypertension, but median systolic blood pressure reductions following ultrasound ablation were highly variable in the first-in-man study, according to Felix Mahfoud, MD, of Saarland University Hospital in Homburg, Germany, a coinvestigator on the study who discussed the findings at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

Of several strategies being pursued to separate those most likely to gain a major benefit, simply measuring carotid body activity is now emerging as particularly promising.

“Patients with a high degree of carotid body activity had a significantly larger fall in blood pressure versus all other methods of grouping patients,” Dr. Mahfoud reported.

The carotid body is a “grain-size” organ of about 2 mm in size that sits on the carotid bifurcation. It communicates directly with the brain to alter sympathetic activity in response to changing levels of such physiologic variable as oxygen, carbon dioxide, and pH, according to Dr. Mahfoud.

In a 2016 proof-of-principle study conducted in resistant hypertension patients, surgical resection of the carotid body was associated with a median 18–mm Hg reduction in systolic blood pressure (SBP) on 24-hour ambulatory monitoring that was sustained through 24 months (Narkiewicz K et al. JACC Basic Transl Sci. 2016;29:313-24).

Subsequently, ultrasound ablation of the carotid body was by way of a transcatheter approach. Dr. Mahfoud’s unpublished first-in-man study, conducted in 2018 enrolled 38 patients with resistant hypertension. The median reductions from baseline of 7-8 mm Hg at 1, 3, and 6 months were significant (P less than .01), but the benefit was disappointingly modest.

However, the variability was large. Some patients achieved SBP reductions of up to 20 mm Hg at 6 months, prompting additional analyses to understand if the best responders could be identified. When compared to the mean reduction of 7 mm Hg at 6 months, this represented a 13–mm Hg additional reduction. There are now several potential approaches being considered.

In addition to carotid body activity, which is readily measured and has substantial potential to serve as a routine selection criterion, isolated systolic hypertension (ISH) was also found to be a discriminator for response. For those with ISH, which Dr. Mahfoud noted is also characterized as “stiff arteries,” SBP reductions at 6 months were negligible, but in those without ISH, the median reduction from baseline was 11 mm Hg.

Further investigations are now planned to evaluate potential predictors of response, according to Dr. Mahfoud. He believes carotid body ablation might have advantages over alternatives, including other experimental therapies, in at least some patients.

To deliver ultrasound ablation in the first-in-man study, a propriety catheter (Cibiem transvenous system) was advanced through the jugular vein guided with intravascular ultrasound. When the carotid body was reached, two to three ultrasound ablations of 8-12 seconds each were applied. The procedure time was 20-30 minutes.

Initially, an arterial approach to the carotid body was used. However, after a transient ischemic attack early in the series, the approach was switched to the jugular vein. There have been no serious subsequent procedural-related complications since.

Although the median SBP reductions were modest, they were not insignificant in a population selected for severe resistant hypertension. The median SBP at entry was 180 mm Hg in patients taking a median of 4.5 antihypertensive drugs, according to Dr. Mahfoud.

In other words, this approach still retains promise for selected patients if larger studies demonstrate that response can be predicted, and the data continue to support tolerability.

A venous approach to the carotid body with intravascular ultrasound guidance and therapeutic ultrasound appears “to offer a safe and effective treatment option in resistant hypertension,” according to Dr. Mahfoud. “A companion diagnostic test is being developed to determine whether patients are likely to respond to this therapy.”

Dr. Mahfoud reports financial relationships with Medtronic, St. Jude, and ReCor.

This article was updated to clarify the study details and correct misspellings of the presenter's name.

SOURCE: CRT 2020.

NATIONAL HARBOR, MD. – Of characteristics that might predict which patients with resistant hypertension will respond to carotid body ablation, the relative activity of the carotid body organ itself might be critical for moving this technology forward, an investigator on a first-in-man study suggests.

The study, first presented in 2018 at the European Society of Cardiology congress, showed carotid body ablation resulted in significant but modest reductions in blood pressure in patients with resistant hypertension.

Ted Bosworth/MDedge News

For many reasons, the carotid body is an attractive target for sustained or indefinite control of resistant hypertension, but median systolic blood pressure reductions following ultrasound ablation were highly variable in the first-in-man study, according to Felix Mahfoud, MD, of Saarland University Hospital in Homburg, Germany, a coinvestigator on the study who discussed the findings at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

Of several strategies being pursued to separate those most likely to gain a major benefit, simply measuring carotid body activity is now emerging as particularly promising.

“Patients with a high degree of carotid body activity had a significantly larger fall in blood pressure versus all other methods of grouping patients,” Dr. Mahfoud reported.

The carotid body is a “grain-size” organ of about 2 mm in size that sits on the carotid bifurcation. It communicates directly with the brain to alter sympathetic activity in response to changing levels of such physiologic variable as oxygen, carbon dioxide, and pH, according to Dr. Mahfoud.

In a 2016 proof-of-principle study conducted in resistant hypertension patients, surgical resection of the carotid body was associated with a median 18–mm Hg reduction in systolic blood pressure (SBP) on 24-hour ambulatory monitoring that was sustained through 24 months (Narkiewicz K et al. JACC Basic Transl Sci. 2016;29:313-24).

Subsequently, ultrasound ablation of the carotid body was by way of a transcatheter approach. Dr. Mahfoud’s unpublished first-in-man study, conducted in 2018 enrolled 38 patients with resistant hypertension. The median reductions from baseline of 7-8 mm Hg at 1, 3, and 6 months were significant (P less than .01), but the benefit was disappointingly modest.

However, the variability was large. Some patients achieved SBP reductions of up to 20 mm Hg at 6 months, prompting additional analyses to understand if the best responders could be identified. When compared to the mean reduction of 7 mm Hg at 6 months, this represented a 13–mm Hg additional reduction. There are now several potential approaches being considered.

In addition to carotid body activity, which is readily measured and has substantial potential to serve as a routine selection criterion, isolated systolic hypertension (ISH) was also found to be a discriminator for response. For those with ISH, which Dr. Mahfoud noted is also characterized as “stiff arteries,” SBP reductions at 6 months were negligible, but in those without ISH, the median reduction from baseline was 11 mm Hg.

Further investigations are now planned to evaluate potential predictors of response, according to Dr. Mahfoud. He believes carotid body ablation might have advantages over alternatives, including other experimental therapies, in at least some patients.

To deliver ultrasound ablation in the first-in-man study, a propriety catheter (Cibiem transvenous system) was advanced through the jugular vein guided with intravascular ultrasound. When the carotid body was reached, two to three ultrasound ablations of 8-12 seconds each were applied. The procedure time was 20-30 minutes.

Initially, an arterial approach to the carotid body was used. However, after a transient ischemic attack early in the series, the approach was switched to the jugular vein. There have been no serious subsequent procedural-related complications since.

Although the median SBP reductions were modest, they were not insignificant in a population selected for severe resistant hypertension. The median SBP at entry was 180 mm Hg in patients taking a median of 4.5 antihypertensive drugs, according to Dr. Mahfoud.

In other words, this approach still retains promise for selected patients if larger studies demonstrate that response can be predicted, and the data continue to support tolerability.

A venous approach to the carotid body with intravascular ultrasound guidance and therapeutic ultrasound appears “to offer a safe and effective treatment option in resistant hypertension,” according to Dr. Mahfoud. “A companion diagnostic test is being developed to determine whether patients are likely to respond to this therapy.”

Dr. Mahfoud reports financial relationships with Medtronic, St. Jude, and ReCor.

This article was updated to clarify the study details and correct misspellings of the presenter's name.

SOURCE: CRT 2020.

NATIONAL HARBOR, MD. – Of characteristics that might predict which patients with resistant hypertension will respond to carotid body ablation, the relative activity of the carotid body organ itself might be critical for moving this technology forward, an investigator on a first-in-man study suggests.

The study, first presented in 2018 at the European Society of Cardiology congress, showed carotid body ablation resulted in significant but modest reductions in blood pressure in patients with resistant hypertension.

Ted Bosworth/MDedge News

For many reasons, the carotid body is an attractive target for sustained or indefinite control of resistant hypertension, but median systolic blood pressure reductions following ultrasound ablation were highly variable in the first-in-man study, according to Felix Mahfoud, MD, of Saarland University Hospital in Homburg, Germany, a coinvestigator on the study who discussed the findings at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

Of several strategies being pursued to separate those most likely to gain a major benefit, simply measuring carotid body activity is now emerging as particularly promising.

“Patients with a high degree of carotid body activity had a significantly larger fall in blood pressure versus all other methods of grouping patients,” Dr. Mahfoud reported.

The carotid body is a “grain-size” organ of about 2 mm in size that sits on the carotid bifurcation. It communicates directly with the brain to alter sympathetic activity in response to changing levels of such physiologic variable as oxygen, carbon dioxide, and pH, according to Dr. Mahfoud.

In a 2016 proof-of-principle study conducted in resistant hypertension patients, surgical resection of the carotid body was associated with a median 18–mm Hg reduction in systolic blood pressure (SBP) on 24-hour ambulatory monitoring that was sustained through 24 months (Narkiewicz K et al. JACC Basic Transl Sci. 2016;29:313-24).

Subsequently, ultrasound ablation of the carotid body was by way of a transcatheter approach. Dr. Mahfoud’s unpublished first-in-man study, conducted in 2018 enrolled 38 patients with resistant hypertension. The median reductions from baseline of 7-8 mm Hg at 1, 3, and 6 months were significant (P less than .01), but the benefit was disappointingly modest.

However, the variability was large. Some patients achieved SBP reductions of up to 20 mm Hg at 6 months, prompting additional analyses to understand if the best responders could be identified. When compared to the mean reduction of 7 mm Hg at 6 months, this represented a 13–mm Hg additional reduction. There are now several potential approaches being considered.

In addition to carotid body activity, which is readily measured and has substantial potential to serve as a routine selection criterion, isolated systolic hypertension (ISH) was also found to be a discriminator for response. For those with ISH, which Dr. Mahfoud noted is also characterized as “stiff arteries,” SBP reductions at 6 months were negligible, but in those without ISH, the median reduction from baseline was 11 mm Hg.

Further investigations are now planned to evaluate potential predictors of response, according to Dr. Mahfoud. He believes carotid body ablation might have advantages over alternatives, including other experimental therapies, in at least some patients.

To deliver ultrasound ablation in the first-in-man study, a propriety catheter (Cibiem transvenous system) was advanced through the jugular vein guided with intravascular ultrasound. When the carotid body was reached, two to three ultrasound ablations of 8-12 seconds each were applied. The procedure time was 20-30 minutes.

Initially, an arterial approach to the carotid body was used. However, after a transient ischemic attack early in the series, the approach was switched to the jugular vein. There have been no serious subsequent procedural-related complications since.

Although the median SBP reductions were modest, they were not insignificant in a population selected for severe resistant hypertension. The median SBP at entry was 180 mm Hg in patients taking a median of 4.5 antihypertensive drugs, according to Dr. Mahfoud.

In other words, this approach still retains promise for selected patients if larger studies demonstrate that response can be predicted, and the data continue to support tolerability.

A venous approach to the carotid body with intravascular ultrasound guidance and therapeutic ultrasound appears “to offer a safe and effective treatment option in resistant hypertension,” according to Dr. Mahfoud. “A companion diagnostic test is being developed to determine whether patients are likely to respond to this therapy.”

Dr. Mahfoud reports financial relationships with Medtronic, St. Jude, and ReCor.

This article was updated to clarify the study details and correct misspellings of the presenter's name.

SOURCE: CRT 2020.

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

Wikimedia Commons/FitzColinGerald/ Creative Commons License

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

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

“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”

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

“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”

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

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

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

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

Dr. Edgerton highlighted why this agreement between the two agencies is so important.

“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”

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

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

gtwachtman@mdedge.com

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

Wikimedia Commons/FitzColinGerald/ Creative Commons License

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

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

“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”

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

“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”

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

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

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

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

Dr. Edgerton highlighted why this agreement between the two agencies is so important.

“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”

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

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

gtwachtman@mdedge.com

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

Wikimedia Commons/FitzColinGerald/ Creative Commons License

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

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

“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”

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

“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”

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

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

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

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

Dr. Edgerton highlighted why this agreement between the two agencies is so important.

“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”

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

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

gtwachtman@mdedge.com