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Use the AGA Clinical Guidelines app to participate in MACRA
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
AGA Future Leaders Program receives national recognition
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
Get involved with AGA
We’re soliciting members to serve in AGA leadership positions – as committee and center members, as well as on the AGA Institute Governing Board. This is an opportunity to network with other physicians and scientists, pursue a special interest, and make an impact in an area that is important to you.
Join a committee or center
AGA and AGA Institute are seeking members to serve on several committees and centers that recommend and oversee new and existing policies and programs. Terms will start in June 2018; nominations must be received by Nov. 1, 2017. Members can either nominate themselves or other members. For more information on the positions available, take a look at the AGA Committee page, http://www.gastro.org/about/people/committees.
Serve in a leadership position
The AGA Nominating Committee is in the midst of identifying candidates to join the governing board – in the offices of vice president, clinical research councillor, and practice councillor – as well as 10 nominees for the 2018-2019 AGA Nominating Committee. To learn more, or to nominate yourself or a colleague, email [email protected]. Nominations are due by Oct. 1, 2017; earlier submissions are encouraged.
We’re soliciting members to serve in AGA leadership positions – as committee and center members, as well as on the AGA Institute Governing Board. This is an opportunity to network with other physicians and scientists, pursue a special interest, and make an impact in an area that is important to you.
Join a committee or center
AGA and AGA Institute are seeking members to serve on several committees and centers that recommend and oversee new and existing policies and programs. Terms will start in June 2018; nominations must be received by Nov. 1, 2017. Members can either nominate themselves or other members. For more information on the positions available, take a look at the AGA Committee page, http://www.gastro.org/about/people/committees.
Serve in a leadership position
The AGA Nominating Committee is in the midst of identifying candidates to join the governing board – in the offices of vice president, clinical research councillor, and practice councillor – as well as 10 nominees for the 2018-2019 AGA Nominating Committee. To learn more, or to nominate yourself or a colleague, email [email protected]. Nominations are due by Oct. 1, 2017; earlier submissions are encouraged.
We’re soliciting members to serve in AGA leadership positions – as committee and center members, as well as on the AGA Institute Governing Board. This is an opportunity to network with other physicians and scientists, pursue a special interest, and make an impact in an area that is important to you.
Join a committee or center
AGA and AGA Institute are seeking members to serve on several committees and centers that recommend and oversee new and existing policies and programs. Terms will start in June 2018; nominations must be received by Nov. 1, 2017. Members can either nominate themselves or other members. For more information on the positions available, take a look at the AGA Committee page, http://www.gastro.org/about/people/committees.
Serve in a leadership position
The AGA Nominating Committee is in the midst of identifying candidates to join the governing board – in the offices of vice president, clinical research councillor, and practice councillor – as well as 10 nominees for the 2018-2019 AGA Nominating Committee. To learn more, or to nominate yourself or a colleague, email [email protected]. Nominations are due by Oct. 1, 2017; earlier submissions are encouraged.
Mark your calendar: 2018 AGA grants cycle announced
The AGA Research Foundation is excited to announce the start of its 2018 Research Grants cycle. This year the foundation will be awarding over $2 million in funding to support researchers within gastroenterology and hepatology. Now is your chance to view upcoming opportunities and plan your applications. Learn more below about the first application due in August, and visit the AGA Research Funding website (www.gastro.org/research-funding) for the full list. Contact [email protected] with any questions.
Applications due: Aug. 4, 2017
AGA-R. Robert & Sally Funderburg Research Award in Gastric Cancer
This award provides $50,000 per year for 2 years to an established investigator working on novel approaches in gastric cancer research. For the past 25 years, this $100,000 award has enhanced the fundamental understanding of gastric cancer pathobiology toward ultimately developing a cure for the disease.
The AGA Research Foundation is excited to announce the start of its 2018 Research Grants cycle. This year the foundation will be awarding over $2 million in funding to support researchers within gastroenterology and hepatology. Now is your chance to view upcoming opportunities and plan your applications. Learn more below about the first application due in August, and visit the AGA Research Funding website (www.gastro.org/research-funding) for the full list. Contact [email protected] with any questions.
Applications due: Aug. 4, 2017
AGA-R. Robert & Sally Funderburg Research Award in Gastric Cancer
This award provides $50,000 per year for 2 years to an established investigator working on novel approaches in gastric cancer research. For the past 25 years, this $100,000 award has enhanced the fundamental understanding of gastric cancer pathobiology toward ultimately developing a cure for the disease.
The AGA Research Foundation is excited to announce the start of its 2018 Research Grants cycle. This year the foundation will be awarding over $2 million in funding to support researchers within gastroenterology and hepatology. Now is your chance to view upcoming opportunities and plan your applications. Learn more below about the first application due in August, and visit the AGA Research Funding website (www.gastro.org/research-funding) for the full list. Contact [email protected] with any questions.
Applications due: Aug. 4, 2017
AGA-R. Robert & Sally Funderburg Research Award in Gastric Cancer
This award provides $50,000 per year for 2 years to an established investigator working on novel approaches in gastric cancer research. For the past 25 years, this $100,000 award has enhanced the fundamental understanding of gastric cancer pathobiology toward ultimately developing a cure for the disease.
Crohn’s & Colitis Congress registration open
Join the Crohn’s & Colitis Foundation and AGA for the inaugural Crohn’s & Colitis Congress™. Expand your knowledge, network with inflammatory bowel diseases (IBD) leaders across multiple disciplines and get inspired to improve patient care.
The Crohn’s & Colitis Congress, taking place Jan. 18-20, 2018 in Las Vegas, combines the strengths of the nation’s leading IBD patient organization, Crohn’s & Colitis Foundation, and the premier GI professional association, AGA. Together we are committed to convening the greatest minds in IBD to transform patient care and accelerate the pace of research.
The Crohn’s & Colitis Congress offers a bold multidisciplinary, clinically focused and forward-thinking program. The organizing committee and faculty represent key disciplines involved in the comprehensive care of IBD patients, as well as the foremost minds in research.
Sessions will emphasize case studies with multidisciplinary panel discussions covering:
- • Management of complicated IBD
- • Defining optimal treatment algorithms
- • Clinical and research challenges
Take a critical step toward finding cures and improving the lives of adults and children living with IBD. Learn more about the congress and register today by visiting www.crohnscolitiscongress.org.
Join the Crohn’s & Colitis Foundation and AGA for the inaugural Crohn’s & Colitis Congress™. Expand your knowledge, network with inflammatory bowel diseases (IBD) leaders across multiple disciplines and get inspired to improve patient care.
The Crohn’s & Colitis Congress, taking place Jan. 18-20, 2018 in Las Vegas, combines the strengths of the nation’s leading IBD patient organization, Crohn’s & Colitis Foundation, and the premier GI professional association, AGA. Together we are committed to convening the greatest minds in IBD to transform patient care and accelerate the pace of research.
The Crohn’s & Colitis Congress offers a bold multidisciplinary, clinically focused and forward-thinking program. The organizing committee and faculty represent key disciplines involved in the comprehensive care of IBD patients, as well as the foremost minds in research.
Sessions will emphasize case studies with multidisciplinary panel discussions covering:
- • Management of complicated IBD
- • Defining optimal treatment algorithms
- • Clinical and research challenges
Take a critical step toward finding cures and improving the lives of adults and children living with IBD. Learn more about the congress and register today by visiting www.crohnscolitiscongress.org.
Join the Crohn’s & Colitis Foundation and AGA for the inaugural Crohn’s & Colitis Congress™. Expand your knowledge, network with inflammatory bowel diseases (IBD) leaders across multiple disciplines and get inspired to improve patient care.
The Crohn’s & Colitis Congress, taking place Jan. 18-20, 2018 in Las Vegas, combines the strengths of the nation’s leading IBD patient organization, Crohn’s & Colitis Foundation, and the premier GI professional association, AGA. Together we are committed to convening the greatest minds in IBD to transform patient care and accelerate the pace of research.
The Crohn’s & Colitis Congress offers a bold multidisciplinary, clinically focused and forward-thinking program. The organizing committee and faculty represent key disciplines involved in the comprehensive care of IBD patients, as well as the foremost minds in research.
Sessions will emphasize case studies with multidisciplinary panel discussions covering:
- • Management of complicated IBD
- • Defining optimal treatment algorithms
- • Clinical and research challenges
Take a critical step toward finding cures and improving the lives of adults and children living with IBD. Learn more about the congress and register today by visiting www.crohnscolitiscongress.org.
New research grant will support pediatric genomics research
The AGA Research Foundation has partnered with the Rady Children’s Institute of Genomic Medicine to establish the AGA-Rady Children’s Institute of Genomic Medicine Research Scholar Award in Pediatric Genomics. This award will support one promising young investigator conducting research that utilizes genomics to enhance our fundamental understanding of childhood digestive diseases.
This newly established award will provide $90,000 per year for 3 years to one investigator. The funded research must be conducted at Rady Children’s Institute for Genomic Medicine in San Diego starting July 2018.
Stay tuned for additional details and information on how to apply for this grant in summer 2017. More information on this new award is available on the Rady Children’s Hospital website.
The AGA Research Foundation has partnered with the Rady Children’s Institute of Genomic Medicine to establish the AGA-Rady Children’s Institute of Genomic Medicine Research Scholar Award in Pediatric Genomics. This award will support one promising young investigator conducting research that utilizes genomics to enhance our fundamental understanding of childhood digestive diseases.
This newly established award will provide $90,000 per year for 3 years to one investigator. The funded research must be conducted at Rady Children’s Institute for Genomic Medicine in San Diego starting July 2018.
Stay tuned for additional details and information on how to apply for this grant in summer 2017. More information on this new award is available on the Rady Children’s Hospital website.
The AGA Research Foundation has partnered with the Rady Children’s Institute of Genomic Medicine to establish the AGA-Rady Children’s Institute of Genomic Medicine Research Scholar Award in Pediatric Genomics. This award will support one promising young investigator conducting research that utilizes genomics to enhance our fundamental understanding of childhood digestive diseases.
This newly established award will provide $90,000 per year for 3 years to one investigator. The funded research must be conducted at Rady Children’s Institute for Genomic Medicine in San Diego starting July 2018.
Stay tuned for additional details and information on how to apply for this grant in summer 2017. More information on this new award is available on the Rady Children’s Hospital website.
Become an AGA Fellow – AGA’s highest level of membership
AGA recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship. AGA fellowship helps open doors, creates connections, and offers widespread value and recognition. Applicants can choose to apply for fellowship in either clinical practice (private or academic) or in research (basic or clinical).
Gain recognition as a distinguished GI professional and apply today by visiting www.gastro.org/fellowship. This website includes the full list of benefits and criteria for fellowship.
Be honored for your contributions and commitment to the GI field. The deadline for submissions is Monday, July 31, 2017.
AGA recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship. AGA fellowship helps open doors, creates connections, and offers widespread value and recognition. Applicants can choose to apply for fellowship in either clinical practice (private or academic) or in research (basic or clinical).
Gain recognition as a distinguished GI professional and apply today by visiting www.gastro.org/fellowship. This website includes the full list of benefits and criteria for fellowship.
Be honored for your contributions and commitment to the GI field. The deadline for submissions is Monday, July 31, 2017.
AGA recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship. AGA fellowship helps open doors, creates connections, and offers widespread value and recognition. Applicants can choose to apply for fellowship in either clinical practice (private or academic) or in research (basic or clinical).
Gain recognition as a distinguished GI professional and apply today by visiting www.gastro.org/fellowship. This website includes the full list of benefits and criteria for fellowship.
Be honored for your contributions and commitment to the GI field. The deadline for submissions is Monday, July 31, 2017.
AGA makes six recommendations to FDA on interchangeable biosimilars
Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments.
1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.
Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise.
2. The agency should use caution when allowing extrapolation for pediatric indications.
Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.
3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.
Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.
4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.
A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products.
5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.
AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication.
6. Prescribing physicians must be empowered with the ability to prevent nonmedical switching from a reference product to an interchangeable product.
AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health care providers must be empowered to be aware of and prevent nonmedical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars.
AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.
Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments.
1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.
Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise.
2. The agency should use caution when allowing extrapolation for pediatric indications.
Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.
3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.
Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.
4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.
A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products.
5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.
AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication.
6. Prescribing physicians must be empowered with the ability to prevent nonmedical switching from a reference product to an interchangeable product.
AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health care providers must be empowered to be aware of and prevent nonmedical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars.
AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.
Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments.
1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.
Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise.
2. The agency should use caution when allowing extrapolation for pediatric indications.
Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.
3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.
Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.
4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.
A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products.
5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.
AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication.
6. Prescribing physicians must be empowered with the ability to prevent nonmedical switching from a reference product to an interchangeable product.
AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health care providers must be empowered to be aware of and prevent nonmedical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars.
AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.
Are you prepared for MACRA?
MACRA (Medicare Access and CHIP Reauthorization Act of 2015) replaces the flawed sustainable growth rate (SGR) formula and significantly changes the way Medicare pays physicians.
Many things about the Affordable Care Act (ACA; Obamacare) are likely to change under the new administration, but MACRA and the commitment to cost-effective, value-based care is here to stay. MACRA is separate from the ACA. Congress overwhelmingly passed MACRA legislation with bipartisan support. MACRA will eventually transition physicians toward more value-based payments.
It is important to understand MACRA to ensure you are doing everything required under the current rules in 2017. Ignore MACRA in 2017 and you will face an automatic reduction of 4% to your payments under Medicare in 2019.
AGA offers educational webinars and videos to help you prepare. Visit gastro.org/MACRA to learn more.
MACRA (Medicare Access and CHIP Reauthorization Act of 2015) replaces the flawed sustainable growth rate (SGR) formula and significantly changes the way Medicare pays physicians.
Many things about the Affordable Care Act (ACA; Obamacare) are likely to change under the new administration, but MACRA and the commitment to cost-effective, value-based care is here to stay. MACRA is separate from the ACA. Congress overwhelmingly passed MACRA legislation with bipartisan support. MACRA will eventually transition physicians toward more value-based payments.
It is important to understand MACRA to ensure you are doing everything required under the current rules in 2017. Ignore MACRA in 2017 and you will face an automatic reduction of 4% to your payments under Medicare in 2019.
AGA offers educational webinars and videos to help you prepare. Visit gastro.org/MACRA to learn more.
MACRA (Medicare Access and CHIP Reauthorization Act of 2015) replaces the flawed sustainable growth rate (SGR) formula and significantly changes the way Medicare pays physicians.
Many things about the Affordable Care Act (ACA; Obamacare) are likely to change under the new administration, but MACRA and the commitment to cost-effective, value-based care is here to stay. MACRA is separate from the ACA. Congress overwhelmingly passed MACRA legislation with bipartisan support. MACRA will eventually transition physicians toward more value-based payments.
It is important to understand MACRA to ensure you are doing everything required under the current rules in 2017. Ignore MACRA in 2017 and you will face an automatic reduction of 4% to your payments under Medicare in 2019.
AGA offers educational webinars and videos to help you prepare. Visit gastro.org/MACRA to learn more.
2018 AGA Fellows Program now accepting applications
The application period for the 2018 AGA Fellows Program is now open. The program recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship.
AGA Fellows receive this honor from AGA for their superior professional achievement in clinical private or academic practice and in basic or clinical research.
AGA Fellows receive:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- A listing on the AGA website.
And more.
Apply today to join this international community of excellence.
Find more information, including the list of benefits and criteria for fellowship, at www.gastro.org/fellowship. The deadline for application submissions is Monday, July 31, 2017.
The application period for the 2018 AGA Fellows Program is now open. The program recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship.
AGA Fellows receive this honor from AGA for their superior professional achievement in clinical private or academic practice and in basic or clinical research.
AGA Fellows receive:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- A listing on the AGA website.
And more.
Apply today to join this international community of excellence.
Find more information, including the list of benefits and criteria for fellowship, at www.gastro.org/fellowship. The deadline for application submissions is Monday, July 31, 2017.
The application period for the 2018 AGA Fellows Program is now open. The program recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship.
AGA Fellows receive this honor from AGA for their superior professional achievement in clinical private or academic practice and in basic or clinical research.
AGA Fellows receive:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- A listing on the AGA website.
And more.
Apply today to join this international community of excellence.
Find more information, including the list of benefits and criteria for fellowship, at www.gastro.org/fellowship. The deadline for application submissions is Monday, July 31, 2017.