In This Week’s Issue:
1. LAN: Join PIPC in Seeking an Extension of TODAY’s Deadline for New Workgroups, click here.
2. Inside Health Policy: Patient Engagement: The New Frontier in Drug Development, click here to view the entire article (subscription only).
3. JAMA: The Future of AHRQ's Health Services Research, click here to view the article.
4. PCORI Board Approves $65.7 Million in Research Awards, click here to view the press release
5. Morning Consult: The Unseen Side Effects of Psoriasis, click here to view the blog post.
6. Blog: Putting Patients at the Center of the Clinical Pathways Debate, click here to view the blog post.
7. The PCORI Blog: Leveraging PCORnet to Combat Obesity; Trust in Patient-Centered Research, click here and here to view the blog posts.
8. Video: Austin Frakt on the Importance of Patients Making Informed Care Decisions, click here to view the video.
1. LAN: Join PIPC in Seeking an Extension of TODAY’s Deadline for New Workgroups, click here.
2. Inside Health Policy: Patient Engagement: The New Frontier in Drug Development, click here to view the entire article (subscription only).
3. JAMA: The Future of AHRQ's Health Services Research, click here to view the article.
4. PCORI Board Approves $65.7 Million in Research Awards, click here to view the press release
5. Morning Consult: The Unseen Side Effects of Psoriasis, click here to view the blog post.
6. Blog: Putting Patients at the Center of the Clinical Pathways Debate, click here to view the blog post.
7. The PCORI Blog: Leveraging PCORnet to Combat Obesity; Trust in Patient-Centered Research, click here and here to view the blog posts.
8. Video: Austin Frakt on the Importance of Patients Making Informed Care Decisions, click here to view the video.
1. LAN: Join PIPC in Seeking an Extension of TODAY’s Deadline for Nominations to New Workgroups
The Health Care Payment Learning and Action Network (LAN) convened a call one week ago on August 17, 2015 presenting an educational slide presentation to LAN participants that should be made available soon, and announcing that the LAN is recruiting nominations for two additional workgroups, due TODAY August 24, 2015. PIPC has requested to MITRE that the deadline be extended to allow for sufficient time to recruit patient participants. It is vitally important that patients serve on these types of workgroups, even if their technical nature is challenging. Patients are needed to advocate for value and quality determinations to be based on outcomes that matter to patients. Otherwise, the metrics for success of new alternative payment models will not be consistent with principles for patient-centeredness. Email MITRE directly at [email protected] to also request an extension of the deadline for recruitment of patient participants and a clear description of the role for patients in this initiative. Send nominations TODAY to the Population-Based Payment Work Group here, or the Clinical Episodes Payment Work Group here. (MITRE requests applicants do not send résumés.)
The second and third LAN work groups for which MITRE is recruiting participants are:
Population-Based Payment (PBP) Work Group: The next work group to be launched will focus on the most effective way to align the nation’s payer and provider efforts around PBP models. The work group will focus on six “components” that comprise essential programmatic features of PBP models (e.g., patient attribution, quality measures, and financial benchmarking). For each component, the work group will recommend national payment standards, allowing for variation between different types of PBP models (e.g., physician- vs. hospital-led) and different levels of operational readiness. The work group will tackle each component in a series of six sprints, incorporating input from the LAN. Once a set of recommendations has been finalized, members of the work group will implement them within their networks of influence, with the proximate goal of having 50% of PBP models implementing the recommendations within two years of their finalization.
Clinical Episodes Payment (CEP) Work Group: The third work group, expected to launch in October, will determine the most effective way to align the nation’s payer and provider efforts around clinical episode-based payment by focusing on a series of episodes that when combined represent a spectrum of episode types. The first will be joint replacement. Medical cancer care, maternity care, and cardiac care are under consideration to follow. The group will approach its work in a series of sprints to define the key technical components, such as episode definition, quality measures, and benchmarking. One preliminary proximate goal is for 5-10 large payers and 5-10 large provider systems to use the findings to begin to experiment with a wider variety of episode types within one year of finalization.
Candidates are requested to have proven strengths in one and preferably more of the following skill sets:
Deep and broad knowledge of the health care payment reform landscape Experience with designing and implementing APMs working with multiple stakeholders of different perspectives on complex health system issues Experience in bringing the patient or consumer perspective to payment models People who are good compromisers and creative policy thinkers Researchers/policy experts with knowledge of the complexities of these types of proposals Experts in methodological approaches including benchmarking, risk adjustment, quality measures, etc Additional criteria for the Population-Based Payment Work Group:
Experience with designing and/or implementing population-based payment models from one of the following perspectives: Payer-led, physician-led, or hospital-led Experience with integrating critical non-medical health services such as behavioral health and social services with medical care is a plusAdditional criteria for the Clinical Episodes Payment Work Group:
Experience with designing, implementing and/or evaluating different types of clinical episode payment models Providers with knowledge on care patterns for each of the conditions chosen Consumers/patients with understanding of the conditions and clinical episodes chosenAccording to MITRE, the contractor managing the LAN for CMS, these work groups will consist of approximately 15 core members and are expected to work at a swift pace and make rapid progress. Members will be expected to participate, at a minimum, in bi-weekly conference calls and one full-day meeting in the Washington, D.C. area, with an average of 2-4 hours of work per week. There is no reimbursement available for travel expenses.
2. Inside Health Policy: Patient Engagement: The New Frontier in Drug Development
In a special report last week, Inside Health Policy reported that “barriers between pharmaceutical companies and the consumers they serve are becoming less rigid as health systems, technology companies, public/private partnerships, patient-centric organizations and others seek to bridge the gap to improve pharmaceuticals' value to consumers and help the industry discover cures for the most scientifically vexing diseases. At the center of this a federal regulatory agency that is also eager to engage the public as it works to streamline drug development. All of this under the constraints of a regulatory framework that, to some in the industry and Congress, is operating a generation behind.”
“…Advancements in technology, coupled with changes in the healthcare system and increasing interest among stakeholders in better utilizing the massive amount of patient information, are leading to a systemic change within drug development, a traditionally by-the-book process, experts say. Pharmaceutical companies are moving out of their usual research paradigm and entering into first-of-a-kind partnerships with technology companies to gain better insight into their customers and streamline their drug development operations. As manufacturers seek treatments for unmet needs, organizations both new and old are sprouting up that are focused on gathering information on the patient experience during treatments -- some funded by the government, some funded independently. The FDA is moving its congressionally mandated drug safety surveillance effort out of the pilot stage and is engaging more than ever with organizations that bring together public and private stakeholders to study ways to modernize the clinical trial process. At the center of it all is data, and lots of it.”
“…FDA has taken a calculated approach to patient engagement. Launched in 2008, the Sentinel Initiative is a national electronic system created to track adverse events related to regulated products. The system relies upon resources like electronic health records and insurance claims databases to ’evaluate possible medical product safety issues quickly and securely,’ according to the agency website… Drug manufacturers themselves are also hopping on-board. ‘With the tone of the different stakeholders about what it is and their interest and support of it, real world evidence is moving from a fringe-type element of research to becoming much more of a mainstream focus,’ Marcus Wilson, president of HealthCore told Inside Health Policy.”
“….And with the data that companies like PatientsLikeMe are able to harness, the future holds promise of more collaboration to ease the burdens clinical trials place on the pharmaceutical industry. ;Today I can help a [pharmaceutical] company run a more patient-centric trial,’ [Jeremy] Gilbert [of PatientsLikeMe] said. ‘In three years, I can help them do a risk-benefit trade-off. Whenever we get to that pie in the sky world, there's a database of real world outcomes available to do it.’
“…As multiple organizations begin to make information available to partner companies, issues around integrity and individual interpretation of the data, as well as the nature of the relationship between partnering firms… There are a handful of organizations that are trying to move industry along in that journey. ‘We definitely believe that real-world data that is not from randomized trials can play a number of supplemental roles to help expand what we learn in clinical trials out to segments of the population that weren't included in those trials, out to the use of therapies for indications other than the indication studied in the trial, and, of course, for understanding better how these treatments that look good in trials are impacting patients in everyday clinical practice,’ Joe Selby, executive director of the Patient-Centered Outcomes Research Institute (PCORI), told Inside Health Policy. PCORI is a nonprofit, nongovernmental organization, authorized by Congress in 2010, to help those in the health delivery industry -- including clinicians, insurers, lawmakers and patients -- make informed health decisions based on quality evidence”
Click here to view the entire article (subscription only).
3. JAMA: The Future of AHRQ's Health Services Research
A recent report in JAMA features an interview with AHRQ Director Richard Kronick, PhD. As Kronick comments, “We complement PCORI's focus on comparing individual treatments in 2 important ways. First, we continue to fund research into how physicians and hospitals can quickly put PCORI's discoveries into practice. This does not happen automatically. Second, we try to develop the best ways to communicate clinical discoveries and how to use them so that health systems, clinicians, patients, and families have the best evidence when they need it and know how to use it when making health care decisions. AHRQ and PCORI are in regular contact to coordinate their complementary efforts.” Click here to view the article.
4. PCORI Board Approves $65.7 Million in Research Awards
According to a recent press release, “the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors [has] approved $56.7 million for four large patient-centered studies of treatment options for appendicitis, ways to improve behavioral and mental health care, and options to prevent potentially deadly blood clots in patients getting hip and knee replacements.” Click here to view the press release.
As Healio reported last week, “The funding is part of PCORI’s focus on supporting clinical trials that better reflect the settings and patients health care providers will encounter. Additionally, $9 million will go to fund studies centered on obesity; one on weight loss surgery and one on weight gain in young children taking antibiotics. Research funding, up to $60 million, is awaiting approval from PCORI’s board, which would be used to study the use of new anticoagulation medications and alternative options for treatment-resistant depression. National advocacy organizations, professional societies and associations, payers and key patient and stakeholder groups will be involved in the research, design and implementation of all PCORI-funded studies.” Click here to view the article.
5. Morning Consult: The Unseen Side Effects of Psoriasis
In a blog post published in Morning Consult, Mark G. Lebwohl, MD, FAAD, President of the American Academy of Dermatology comments, “some of the most effective and life-improving treatments for patients with psoriasis are newer, costlier biologic medications. Years of scientific research and innovation have yielded biologic treatments that are life-changing for patients with psoriasis. I’ve witnessed first-hand those scales and patches disappear as a result of biologic treatments, greatly improving not only a patient’s medical condition, but also quality of life. But insurance policies, coverage determinations and out-of-pocket expenses put these treatments out-of-reach for many patients… To choose a cheaper drug option is often to choose a drug that just isn’t as effective or has more side effects… However, a first step to help ease this burden is within our reach. When Congress returns to Washington in a few weeks, they must act immediately to help our nation’s patients. The Patients’ Access to Treatment Act of 2015 is an important step to help ease financial burdens for patients. If passed, the bill would limit cost-sharing requirements for specialty medications, making these treatments more accessible by reducing patients’ out-of-pocket expenses… While it will take more than one piece of legislation to address our nation’s drug pricing crisis, this bill begins to address the issue for those to whom the issue is most important – our patients.” Click here to view the blog post.
6. NPAF Blog: Putting Patients at the Center of the Clinical Pathways Debate
Alan Balch with the National Patient Advocate Foundation comments, “As conversations around the use of clinical pathways continue, it's important to ensure the process is designed to optimize and personalize treatment protocols for each patient based on individual needs and their physician's clinical judgment — not the financial interests of health care companies...Some pathways, for example, try to pigeonhole physicians into prescribing a limited set of therapies that are preselected by insurance companies, which may hinder patient access to more effective treatments.”
Click here to view the blog post.
7. The PCORI Blog: Leveraging PCORnet to Combat Obesity; Trust in Patient-Centered Research
PCORI’s Rachael Fleurence, PhD and Joe V. Selby, MD, MP commented on The PCORI Blog last week, “As part of our mission to help people make better-informed healthcare decisions, PCORI has funded a range of research projects on obesity. Our latest effort will apply the power of PCORnet, our developing national patient-centered clinical research network, to conduct two compelling comparative effectiveness research (CER) studies in this area—one comparing the health benefits and safety of three available surgical approaches to weight loss and the other looking at whether antibiotic treatments given early in life differ in their tendency to cause excess weight gain in children.” Click here to view the blog post.
In another post on The PCORI Blog, PCORI’s Adrian F. Hernandez comments, “trust is central to the relationship between patients and their clinicians. It's also essential to the relationship between patients and researchers if patients are to fully engage in clinical research...One way to build trust is to include patients in the research process. PCORnet, the National Patient-Centered Clinical Research Network, aims to transform clinical research by engaging patients–and others in the healthcare community—in collaborative partnerships that produce useful clinical knowledge and improve health care.” Click here to view the blog post.
8. Video: Austin Frakt on the Importance of Patients Making Informed Care Decisions
In a video posted by The American Journal of Managed Care, health economist and researcher Austin Frakt, PhD, notes that when patients overestimate the benefits of intervention and underestimate the harms of treatments, they may not be receiving the right forms of care that they should be. He adds that its critically important that patients make informed decisions so that he or she can then add or drop care as needed.” Click here to view the video.
The Health Care Payment Learning and Action Network (LAN) convened a call one week ago on August 17, 2015 presenting an educational slide presentation to LAN participants that should be made available soon, and announcing that the LAN is recruiting nominations for two additional workgroups, due TODAY August 24, 2015. PIPC has requested to MITRE that the deadline be extended to allow for sufficient time to recruit patient participants. It is vitally important that patients serve on these types of workgroups, even if their technical nature is challenging. Patients are needed to advocate for value and quality determinations to be based on outcomes that matter to patients. Otherwise, the metrics for success of new alternative payment models will not be consistent with principles for patient-centeredness. Email MITRE directly at [email protected] to also request an extension of the deadline for recruitment of patient participants and a clear description of the role for patients in this initiative. Send nominations TODAY to the Population-Based Payment Work Group here, or the Clinical Episodes Payment Work Group here. (MITRE requests applicants do not send résumés.)
The second and third LAN work groups for which MITRE is recruiting participants are:
Population-Based Payment (PBP) Work Group: The next work group to be launched will focus on the most effective way to align the nation’s payer and provider efforts around PBP models. The work group will focus on six “components” that comprise essential programmatic features of PBP models (e.g., patient attribution, quality measures, and financial benchmarking). For each component, the work group will recommend national payment standards, allowing for variation between different types of PBP models (e.g., physician- vs. hospital-led) and different levels of operational readiness. The work group will tackle each component in a series of six sprints, incorporating input from the LAN. Once a set of recommendations has been finalized, members of the work group will implement them within their networks of influence, with the proximate goal of having 50% of PBP models implementing the recommendations within two years of their finalization.
Clinical Episodes Payment (CEP) Work Group: The third work group, expected to launch in October, will determine the most effective way to align the nation’s payer and provider efforts around clinical episode-based payment by focusing on a series of episodes that when combined represent a spectrum of episode types. The first will be joint replacement. Medical cancer care, maternity care, and cardiac care are under consideration to follow. The group will approach its work in a series of sprints to define the key technical components, such as episode definition, quality measures, and benchmarking. One preliminary proximate goal is for 5-10 large payers and 5-10 large provider systems to use the findings to begin to experiment with a wider variety of episode types within one year of finalization.
Candidates are requested to have proven strengths in one and preferably more of the following skill sets:
Deep and broad knowledge of the health care payment reform landscape Experience with designing and implementing APMs working with multiple stakeholders of different perspectives on complex health system issues Experience in bringing the patient or consumer perspective to payment models People who are good compromisers and creative policy thinkers Researchers/policy experts with knowledge of the complexities of these types of proposals Experts in methodological approaches including benchmarking, risk adjustment, quality measures, etc Additional criteria for the Population-Based Payment Work Group:
Experience with designing and/or implementing population-based payment models from one of the following perspectives: Payer-led, physician-led, or hospital-led Experience with integrating critical non-medical health services such as behavioral health and social services with medical care is a plusAdditional criteria for the Clinical Episodes Payment Work Group:
Experience with designing, implementing and/or evaluating different types of clinical episode payment models Providers with knowledge on care patterns for each of the conditions chosen Consumers/patients with understanding of the conditions and clinical episodes chosenAccording to MITRE, the contractor managing the LAN for CMS, these work groups will consist of approximately 15 core members and are expected to work at a swift pace and make rapid progress. Members will be expected to participate, at a minimum, in bi-weekly conference calls and one full-day meeting in the Washington, D.C. area, with an average of 2-4 hours of work per week. There is no reimbursement available for travel expenses.
2. Inside Health Policy: Patient Engagement: The New Frontier in Drug Development
In a special report last week, Inside Health Policy reported that “barriers between pharmaceutical companies and the consumers they serve are becoming less rigid as health systems, technology companies, public/private partnerships, patient-centric organizations and others seek to bridge the gap to improve pharmaceuticals' value to consumers and help the industry discover cures for the most scientifically vexing diseases. At the center of this a federal regulatory agency that is also eager to engage the public as it works to streamline drug development. All of this under the constraints of a regulatory framework that, to some in the industry and Congress, is operating a generation behind.”
“…Advancements in technology, coupled with changes in the healthcare system and increasing interest among stakeholders in better utilizing the massive amount of patient information, are leading to a systemic change within drug development, a traditionally by-the-book process, experts say. Pharmaceutical companies are moving out of their usual research paradigm and entering into first-of-a-kind partnerships with technology companies to gain better insight into their customers and streamline their drug development operations. As manufacturers seek treatments for unmet needs, organizations both new and old are sprouting up that are focused on gathering information on the patient experience during treatments -- some funded by the government, some funded independently. The FDA is moving its congressionally mandated drug safety surveillance effort out of the pilot stage and is engaging more than ever with organizations that bring together public and private stakeholders to study ways to modernize the clinical trial process. At the center of it all is data, and lots of it.”
“…FDA has taken a calculated approach to patient engagement. Launched in 2008, the Sentinel Initiative is a national electronic system created to track adverse events related to regulated products. The system relies upon resources like electronic health records and insurance claims databases to ’evaluate possible medical product safety issues quickly and securely,’ according to the agency website… Drug manufacturers themselves are also hopping on-board. ‘With the tone of the different stakeholders about what it is and their interest and support of it, real world evidence is moving from a fringe-type element of research to becoming much more of a mainstream focus,’ Marcus Wilson, president of HealthCore told Inside Health Policy.”
“….And with the data that companies like PatientsLikeMe are able to harness, the future holds promise of more collaboration to ease the burdens clinical trials place on the pharmaceutical industry. ;Today I can help a [pharmaceutical] company run a more patient-centric trial,’ [Jeremy] Gilbert [of PatientsLikeMe] said. ‘In three years, I can help them do a risk-benefit trade-off. Whenever we get to that pie in the sky world, there's a database of real world outcomes available to do it.’
“…As multiple organizations begin to make information available to partner companies, issues around integrity and individual interpretation of the data, as well as the nature of the relationship between partnering firms… There are a handful of organizations that are trying to move industry along in that journey. ‘We definitely believe that real-world data that is not from randomized trials can play a number of supplemental roles to help expand what we learn in clinical trials out to segments of the population that weren't included in those trials, out to the use of therapies for indications other than the indication studied in the trial, and, of course, for understanding better how these treatments that look good in trials are impacting patients in everyday clinical practice,’ Joe Selby, executive director of the Patient-Centered Outcomes Research Institute (PCORI), told Inside Health Policy. PCORI is a nonprofit, nongovernmental organization, authorized by Congress in 2010, to help those in the health delivery industry -- including clinicians, insurers, lawmakers and patients -- make informed health decisions based on quality evidence”
Click here to view the entire article (subscription only).
3. JAMA: The Future of AHRQ's Health Services Research
A recent report in JAMA features an interview with AHRQ Director Richard Kronick, PhD. As Kronick comments, “We complement PCORI's focus on comparing individual treatments in 2 important ways. First, we continue to fund research into how physicians and hospitals can quickly put PCORI's discoveries into practice. This does not happen automatically. Second, we try to develop the best ways to communicate clinical discoveries and how to use them so that health systems, clinicians, patients, and families have the best evidence when they need it and know how to use it when making health care decisions. AHRQ and PCORI are in regular contact to coordinate their complementary efforts.” Click here to view the article.
4. PCORI Board Approves $65.7 Million in Research Awards
According to a recent press release, “the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors [has] approved $56.7 million for four large patient-centered studies of treatment options for appendicitis, ways to improve behavioral and mental health care, and options to prevent potentially deadly blood clots in patients getting hip and knee replacements.” Click here to view the press release.
As Healio reported last week, “The funding is part of PCORI’s focus on supporting clinical trials that better reflect the settings and patients health care providers will encounter. Additionally, $9 million will go to fund studies centered on obesity; one on weight loss surgery and one on weight gain in young children taking antibiotics. Research funding, up to $60 million, is awaiting approval from PCORI’s board, which would be used to study the use of new anticoagulation medications and alternative options for treatment-resistant depression. National advocacy organizations, professional societies and associations, payers and key patient and stakeholder groups will be involved in the research, design and implementation of all PCORI-funded studies.” Click here to view the article.
5. Morning Consult: The Unseen Side Effects of Psoriasis
In a blog post published in Morning Consult, Mark G. Lebwohl, MD, FAAD, President of the American Academy of Dermatology comments, “some of the most effective and life-improving treatments for patients with psoriasis are newer, costlier biologic medications. Years of scientific research and innovation have yielded biologic treatments that are life-changing for patients with psoriasis. I’ve witnessed first-hand those scales and patches disappear as a result of biologic treatments, greatly improving not only a patient’s medical condition, but also quality of life. But insurance policies, coverage determinations and out-of-pocket expenses put these treatments out-of-reach for many patients… To choose a cheaper drug option is often to choose a drug that just isn’t as effective or has more side effects… However, a first step to help ease this burden is within our reach. When Congress returns to Washington in a few weeks, they must act immediately to help our nation’s patients. The Patients’ Access to Treatment Act of 2015 is an important step to help ease financial burdens for patients. If passed, the bill would limit cost-sharing requirements for specialty medications, making these treatments more accessible by reducing patients’ out-of-pocket expenses… While it will take more than one piece of legislation to address our nation’s drug pricing crisis, this bill begins to address the issue for those to whom the issue is most important – our patients.” Click here to view the blog post.
6. NPAF Blog: Putting Patients at the Center of the Clinical Pathways Debate
Alan Balch with the National Patient Advocate Foundation comments, “As conversations around the use of clinical pathways continue, it's important to ensure the process is designed to optimize and personalize treatment protocols for each patient based on individual needs and their physician's clinical judgment — not the financial interests of health care companies...Some pathways, for example, try to pigeonhole physicians into prescribing a limited set of therapies that are preselected by insurance companies, which may hinder patient access to more effective treatments.”
Click here to view the blog post.
7. The PCORI Blog: Leveraging PCORnet to Combat Obesity; Trust in Patient-Centered Research
PCORI’s Rachael Fleurence, PhD and Joe V. Selby, MD, MP commented on The PCORI Blog last week, “As part of our mission to help people make better-informed healthcare decisions, PCORI has funded a range of research projects on obesity. Our latest effort will apply the power of PCORnet, our developing national patient-centered clinical research network, to conduct two compelling comparative effectiveness research (CER) studies in this area—one comparing the health benefits and safety of three available surgical approaches to weight loss and the other looking at whether antibiotic treatments given early in life differ in their tendency to cause excess weight gain in children.” Click here to view the blog post.
In another post on The PCORI Blog, PCORI’s Adrian F. Hernandez comments, “trust is central to the relationship between patients and their clinicians. It's also essential to the relationship between patients and researchers if patients are to fully engage in clinical research...One way to build trust is to include patients in the research process. PCORnet, the National Patient-Centered Clinical Research Network, aims to transform clinical research by engaging patients–and others in the healthcare community—in collaborative partnerships that produce useful clinical knowledge and improve health care.” Click here to view the blog post.
8. Video: Austin Frakt on the Importance of Patients Making Informed Care Decisions
In a video posted by The American Journal of Managed Care, health economist and researcher Austin Frakt, PhD, notes that when patients overestimate the benefits of intervention and underestimate the harms of treatments, they may not be receiving the right forms of care that they should be. He adds that its critically important that patients make informed decisions so that he or she can then add or drop care as needed.” Click here to view the video.
