In This Week’s Issue:
1. Inside Health Policy: 'Patient Groups Seek Key Role In Health Care Payment Learning And Action Network', click here to view the article.
2. NPFW: Save Online Access to Health Information, see below to sign the letter.
3. Not Dead Yet: Disability Advocates Demand Seat At the HHS Table In Design of Value-Based Healthcare Payment Systems, click here to view the letter.
4. PCORI Board Approves PCORnet Trial Award, New Demonstration Projects, click here to view the blog post.
5. Clinical Trials In The Real World, click here to view the article.
6. KevinMD: Putting Patient-Centeredness into Practice, click here to view the article.
7. Video: Incorporating Patient-Reported Outcomes in Drug Labels, click here to view the video.
8. PCORI Blog: Mental Health as a Major Focus of PCORI Funding, click here to view the blog post.
9. Upcoming Events and Webinar, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.
1. Inside Health Policy: 'Patient Groups Seek Key Role In Health Care Payment Learning And Action Network', click here to view the article.
2. NPFW: Save Online Access to Health Information, see below to sign the letter.
3. Not Dead Yet: Disability Advocates Demand Seat At the HHS Table In Design of Value-Based Healthcare Payment Systems, click here to view the letter.
4. PCORI Board Approves PCORnet Trial Award, New Demonstration Projects, click here to view the blog post.
5. Clinical Trials In The Real World, click here to view the article.
6. KevinMD: Putting Patient-Centeredness into Practice, click here to view the article.
7. Video: Incorporating Patient-Reported Outcomes in Drug Labels, click here to view the video.
8. PCORI Blog: Mental Health as a Major Focus of PCORI Funding, click here to view the blog post.
9. Upcoming Events and Webinar, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.
1. Inside Health Policy: 'Patient Groups Seek Key Role In Health Care Payment Learning And Action Network'
As highlighted in an article in Inside Health Policy, "more than 60 patient groups and members of [PIPC] are asking HHS to make the Health Care Payment Learning and Action Network patient-centered by including patient groups in the network and using best practices from the FDA and Patient-Centered Outcomes Research Institute to solicit patient engagement with the initiative. The groups [s]ay that alternative payment models hold significant implications for patients and caregivers, and if patients are not put first, ‘the risk is that the initiative will define value in a 'one size fits all' manner that does not recognize differences among patients, potentially undermining the ability of patients and their providers to tailor care for the outcomes that they prefer and value.’”
While most patient stakeholders agree that paying for “value” rather than “volume” will result in better outcomes for patients, the shift to value-based payment holds significant implications for the patient-centeredness movement and the related issues of patient access and the physician-patient relationship. That’s why PIPC led this letter – to ensure that that patients have a seat at the table in determining how these new payment models are implemented. As PIPC Chairman Tony Coelho told Inside Health Policy, “I look forward to collaborating with HHS to effectively bring the patient voice to their ambitious new framework to move our health care system away from rewarding health providers for the quantity of care they provide and toward rewarding quality. Empowering patients to play an active role in their healthcare should be a strategic and achievable goal of this important work.” Click here to view the article. Click here to ADD YOUR SIGNATURE to the letter.
2. NPFW: Save Online Access to Health Information
According to a recent email alert from the National Partnership for Women and Families (NPWF), “the Consumer Partnership for e-Health (CPeH) has drafted comments responding to CMS's recent proposal to drastically scale back current patient and family engagement requirements in the Electronic Health Record (EHR) “Meaningful Use” incentive program. Please consider signing on in support our comments urging CMS not to weaken the meaningful use program and undermine our hard-fought progress. After working for years to help make our health care system more patient- and family-centered, CMS unexpectedly proposed drastic changes to the patient and family engagement measures finalized in Stage 2 of the Meaningful Use program. The proposed rule would reverse the requirements that at least 5% of patients use online access and/or send a secure message to their provider. For 2015-2017:
-Providers need only show that just one patient actually viewed, downloaded, or transmitted his or her health information.
-For secure messaging, providers need only show that the function was turned on (patients don't need to send, and providers don't need to reply to secure messages).
According to the Partnership, "[Just one patient is a] low bar to set and a drastic retreat from using health IT in meaningful ways… We should be encouraging patients and family caregivers to use their online health information as informed partners in care. And one patient isn’t meaningful enough! If your organization would like to sign on in support of CPeH's comment letter, please email Ali Foti ([email protected]<script cf-hash='f9e31' type="text/javascript"> /* */</script>) as soon as possible."
3. Not Dead Yet: Disability Advocates Demand Seat At the HHS Table In Design of Value-Based Healthcare Payment Systems
On April 30, Not Dead Yet was one of over 70 individual patients and patient organizations that joined the Partnership to Improve Patient Care (PIPC) in a letter to the Department of Health and Human Services (HHS), calling for recognition as stakeholders in the Better, Smarter, Healthier initiative and in the Health Care Payment Learning and Action Network. The next day, Not Dead Yet sent their own letter to Secretary Burwell, emphasizing three points:
Including “patients” among the stakeholders requires more than a token representation of the broad and diverse population of health care consumers. We are specifically concerned that people with disabilities and chronic health conditions are adequately represented in the process. While family members and disability-related professionals should also be included, such individuals and related organizations do not substitute for people with disabilities and the organizations that are run by us.
It is essential that the initiative develop approaches that put individual patient self-determination as the top priority in establishing the value of health care treatments. PIPC rightly points out that a risk in alternative payment models based on “value” is that “value” may be defined in a “one size fits all” manner that does not recognize differences among patients . . .. The urgency of avoiding this error cannot be overstated. If the bottom line is a system that determines value based on “majority rule”, that system will fail to meet the needs of individuals and will violate the core principles of self-determination.
There is a risk that definitions of value that have previously been posited by self-appointed “bioethicists” will be foisted upon the stakeholders. Concepts such as “quality adjusted life years” and “disability adjusted life years” inherently devalue people with disabilities and chronic conditions and should not be used as a basis for the work of the initiative.
Click here to view the letter.
4. PCORI Board Approves PCORnet Trial Award, New Demonstration Projects
According to a recent press release, “the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors, at its May 4 meeting, approved $14 million for the first demonstration project to be conducted using PCORnet, the National Patient-Centered Clinical Research Network, as well as plans for two more PCORnet demonstration projects totaling up to $29.5 million in support… The demonstration projects approved by our Board provide an excellent means to both develop PCORnet's capacities and to support comparative clinical effectiveness research that answers important questions, such as which dose of aspirin is most effective and safest and how best health systems can manage patients' diabetes,’ said Rachael Fleurence, PhD, Director of PCORI's CER Methods and Infrastructure Program. ‘These demonstration studies are an important step in our efforts to transition PCORnet from its development phase into a research-ready national resource.’” Click here to view the press release.
And in a new post on The PCORI Blog, Executive Director Dr. Joe Selby discusses the Institute’s first study through PCORInett – a $14 million clinical trial comparing the benefits and harms of low-dose and regular-strength aspirin in preventing heart attacks and strokes in patients living with heart disease. “We hope that what we learn from the ADAPTABLE study will improve care and outcomes for patients with heart disease,” Dr. Selby comments. “But we're also excited by the prospect that this study will be a major step forward in the effort, by PCORI and others, to leverage data to conduct the kind of research that can help us answer many other health and healthcare questions that patients—and their doctors—face every day.” Click here to view the blog post.
5. Clinical Trials In The Real World
In an article in Forbes, Johns Hopkins professor Sonal Singh discusses the potential for comparative effectiveness research to improve the ability of doctors to individualize care. According to the report, “comparative effectiveness research can help determine which treatments generally work for everyone, but [Singh] notes that its true promise lies in individualizing care. ‘If we can determine that a drug works for me or for people like me, then it's useful. But if we are just creating general information about an entire population, it may not be useful for ultimately improving care.’” Click here to view the article.
6. KevinMD: Putting Patient-Centeredness into Practice
In a post on KevinMD, Michael L. Millenson comments, “imagine patient-centered care explained as a kind of updated Norman Rockwell painting. What you'd get is a recent PBS documentary, Rx: The Quiet Revolution, which, yes, uses a famous Rockwell image of a kindly family physician (Doctor and Doll) to set the stage for what follows...The film also provides data on how this approach helps keep patients healthier and care costs down and its promise for changing care for all. Hence, the ‘Rx’ and ‘revolution’ in the film's title.” Click here to view the article.
7. Video: Incorporating Patient-Reported Outcomes in Drug Labels
During a segment of the Oncology Stakeholders Summit, Spring 2015 series, Bruce Feinberg, DO; Scott Gottlieb, MD; and Michael Kolodziej, MD, discuss their concerns and the concerns of manufacturers regarding the inclusion of information on patient-reported outcomes (PROs) in drug labels. Dr. Gottlieb discusses the FDA's role in allowing the inclusion of PRO data, notes the cumbersome process that manufacturers are faced with when incorporating the data into drug labels, and describes his concerns regarding how PRO data may be interpreted or misinterpreted by patients. For instance, he explains that in the oncology setting, where data regarding a drug's efficacy are often the focus, if data on PROs are included in a drug label, patients may focus instead on quality-of-life claims. Click here to view the video.
8. PCORI Blog: Mental Health as a Major Focus of PCORI Funding
Dr. Bryan Luce and Dr. Marina Broitman comment in a new post on The PCORI Blog, “during May, which is Mental Health Month, we'd like to take the opportunity to highlight the importance of patient-centered clinical research aimed at improving the lives of people with mental illness. Seeking better ways to prevent, diagnose, or treat mental illnesses is a major focus of PCORI's research funding and patient and community engagement activities. Often, people suffering from a mental illness and their families don't know how or where to ask for help. And when they do seek help, they often find little information available about which treatments are likely to work best for an individual patient.” Click here to view the blog post.
9. Upcoming Events and Webinar
ISPOR 20th Annual International MeetingMay 16 - 20, 2015, Philadelphia, PA Click here for details.Academy Health Webinar: Methodological Issues in Big Data Analytics May 7, 2015, 2:00 - 3:300 PM ET Click here for details.October 2015 CEPAC Meeting: Drug Therapies for High Cholesterol October 27, 2015, 10:00 AM - 4:00 PM EDT Click here for details.
North Carolina Translational & Clinical Sciences Institute: Bridges to Advance CER
May 13 - 14, 2015, Research Triangle Park, NC
Click here to register.
Mental Health Twitter Chat
May 19, 2015, 3:00 - 4:00 PM EDT
Join PCORI and others for a Twitter chat about how patient involvement in research is making a difference in mental health. Use #MHTalk to join the conversation.
PCORI Advisory Panel on Improving Healthcare Systems Spring 2015 Meeting
May 27 - 28, 2015
Click here for details.
PCORI Advisory Panel on Rare Disease Spring 2015 Meeting
May 27, 2015, 9:00 AM - 5:00 PM EDT
Click here for details.
Prioritizing Comparative Effectiveness Research Questions for Treatment of Major
Depressive Disorder: A Stakeholder Workshop
June 9, 2015,9:00 AM - 5:00 PM EDT
Click here for details.
Getting to Know PCORI: From Application to Closeout
June 22 - 23, 2015, Atlanta, GA
Click here for details.
11. AHRQ Effective Program Updates
Early Diagnosis, Prevention, and Treatment of C. difficile: Update, click here to comment by May 18.
Noninvasive Treatments for Low Back Pain, click here to comment by May 18.
Home-Based Primary Care Interventions, click here to comment by May 25.
Diabetes Medications for Adults with Type 2 Diabetes: An Update Focused on Monotherapy and Add-On Therapy to Metformin, click here to comment by June 1.
As highlighted in an article in Inside Health Policy, "more than 60 patient groups and members of [PIPC] are asking HHS to make the Health Care Payment Learning and Action Network patient-centered by including patient groups in the network and using best practices from the FDA and Patient-Centered Outcomes Research Institute to solicit patient engagement with the initiative. The groups [s]ay that alternative payment models hold significant implications for patients and caregivers, and if patients are not put first, ‘the risk is that the initiative will define value in a 'one size fits all' manner that does not recognize differences among patients, potentially undermining the ability of patients and their providers to tailor care for the outcomes that they prefer and value.’”
While most patient stakeholders agree that paying for “value” rather than “volume” will result in better outcomes for patients, the shift to value-based payment holds significant implications for the patient-centeredness movement and the related issues of patient access and the physician-patient relationship. That’s why PIPC led this letter – to ensure that that patients have a seat at the table in determining how these new payment models are implemented. As PIPC Chairman Tony Coelho told Inside Health Policy, “I look forward to collaborating with HHS to effectively bring the patient voice to their ambitious new framework to move our health care system away from rewarding health providers for the quantity of care they provide and toward rewarding quality. Empowering patients to play an active role in their healthcare should be a strategic and achievable goal of this important work.” Click here to view the article. Click here to ADD YOUR SIGNATURE to the letter.
2. NPFW: Save Online Access to Health Information
According to a recent email alert from the National Partnership for Women and Families (NPWF), “the Consumer Partnership for e-Health (CPeH) has drafted comments responding to CMS's recent proposal to drastically scale back current patient and family engagement requirements in the Electronic Health Record (EHR) “Meaningful Use” incentive program. Please consider signing on in support our comments urging CMS not to weaken the meaningful use program and undermine our hard-fought progress. After working for years to help make our health care system more patient- and family-centered, CMS unexpectedly proposed drastic changes to the patient and family engagement measures finalized in Stage 2 of the Meaningful Use program. The proposed rule would reverse the requirements that at least 5% of patients use online access and/or send a secure message to their provider. For 2015-2017:
-Providers need only show that just one patient actually viewed, downloaded, or transmitted his or her health information.
-For secure messaging, providers need only show that the function was turned on (patients don't need to send, and providers don't need to reply to secure messages).
According to the Partnership, "[Just one patient is a] low bar to set and a drastic retreat from using health IT in meaningful ways… We should be encouraging patients and family caregivers to use their online health information as informed partners in care. And one patient isn’t meaningful enough! If your organization would like to sign on in support of CPeH's comment letter, please email Ali Foti ([email protected]<script cf-hash='f9e31' type="text/javascript"> /* */</script>) as soon as possible."
3. Not Dead Yet: Disability Advocates Demand Seat At the HHS Table In Design of Value-Based Healthcare Payment Systems
On April 30, Not Dead Yet was one of over 70 individual patients and patient organizations that joined the Partnership to Improve Patient Care (PIPC) in a letter to the Department of Health and Human Services (HHS), calling for recognition as stakeholders in the Better, Smarter, Healthier initiative and in the Health Care Payment Learning and Action Network. The next day, Not Dead Yet sent their own letter to Secretary Burwell, emphasizing three points:
Including “patients” among the stakeholders requires more than a token representation of the broad and diverse population of health care consumers. We are specifically concerned that people with disabilities and chronic health conditions are adequately represented in the process. While family members and disability-related professionals should also be included, such individuals and related organizations do not substitute for people with disabilities and the organizations that are run by us.
It is essential that the initiative develop approaches that put individual patient self-determination as the top priority in establishing the value of health care treatments. PIPC rightly points out that a risk in alternative payment models based on “value” is that “value” may be defined in a “one size fits all” manner that does not recognize differences among patients . . .. The urgency of avoiding this error cannot be overstated. If the bottom line is a system that determines value based on “majority rule”, that system will fail to meet the needs of individuals and will violate the core principles of self-determination.
There is a risk that definitions of value that have previously been posited by self-appointed “bioethicists” will be foisted upon the stakeholders. Concepts such as “quality adjusted life years” and “disability adjusted life years” inherently devalue people with disabilities and chronic conditions and should not be used as a basis for the work of the initiative.
Click here to view the letter.
4. PCORI Board Approves PCORnet Trial Award, New Demonstration Projects
According to a recent press release, “the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors, at its May 4 meeting, approved $14 million for the first demonstration project to be conducted using PCORnet, the National Patient-Centered Clinical Research Network, as well as plans for two more PCORnet demonstration projects totaling up to $29.5 million in support… The demonstration projects approved by our Board provide an excellent means to both develop PCORnet's capacities and to support comparative clinical effectiveness research that answers important questions, such as which dose of aspirin is most effective and safest and how best health systems can manage patients' diabetes,’ said Rachael Fleurence, PhD, Director of PCORI's CER Methods and Infrastructure Program. ‘These demonstration studies are an important step in our efforts to transition PCORnet from its development phase into a research-ready national resource.’” Click here to view the press release.
And in a new post on The PCORI Blog, Executive Director Dr. Joe Selby discusses the Institute’s first study through PCORInett – a $14 million clinical trial comparing the benefits and harms of low-dose and regular-strength aspirin in preventing heart attacks and strokes in patients living with heart disease. “We hope that what we learn from the ADAPTABLE study will improve care and outcomes for patients with heart disease,” Dr. Selby comments. “But we're also excited by the prospect that this study will be a major step forward in the effort, by PCORI and others, to leverage data to conduct the kind of research that can help us answer many other health and healthcare questions that patients—and their doctors—face every day.” Click here to view the blog post.
5. Clinical Trials In The Real World
In an article in Forbes, Johns Hopkins professor Sonal Singh discusses the potential for comparative effectiveness research to improve the ability of doctors to individualize care. According to the report, “comparative effectiveness research can help determine which treatments generally work for everyone, but [Singh] notes that its true promise lies in individualizing care. ‘If we can determine that a drug works for me or for people like me, then it's useful. But if we are just creating general information about an entire population, it may not be useful for ultimately improving care.’” Click here to view the article.
6. KevinMD: Putting Patient-Centeredness into Practice
In a post on KevinMD, Michael L. Millenson comments, “imagine patient-centered care explained as a kind of updated Norman Rockwell painting. What you'd get is a recent PBS documentary, Rx: The Quiet Revolution, which, yes, uses a famous Rockwell image of a kindly family physician (Doctor and Doll) to set the stage for what follows...The film also provides data on how this approach helps keep patients healthier and care costs down and its promise for changing care for all. Hence, the ‘Rx’ and ‘revolution’ in the film's title.” Click here to view the article.
7. Video: Incorporating Patient-Reported Outcomes in Drug Labels
During a segment of the Oncology Stakeholders Summit, Spring 2015 series, Bruce Feinberg, DO; Scott Gottlieb, MD; and Michael Kolodziej, MD, discuss their concerns and the concerns of manufacturers regarding the inclusion of information on patient-reported outcomes (PROs) in drug labels. Dr. Gottlieb discusses the FDA's role in allowing the inclusion of PRO data, notes the cumbersome process that manufacturers are faced with when incorporating the data into drug labels, and describes his concerns regarding how PRO data may be interpreted or misinterpreted by patients. For instance, he explains that in the oncology setting, where data regarding a drug's efficacy are often the focus, if data on PROs are included in a drug label, patients may focus instead on quality-of-life claims. Click here to view the video.
8. PCORI Blog: Mental Health as a Major Focus of PCORI Funding
Dr. Bryan Luce and Dr. Marina Broitman comment in a new post on The PCORI Blog, “during May, which is Mental Health Month, we'd like to take the opportunity to highlight the importance of patient-centered clinical research aimed at improving the lives of people with mental illness. Seeking better ways to prevent, diagnose, or treat mental illnesses is a major focus of PCORI's research funding and patient and community engagement activities. Often, people suffering from a mental illness and their families don't know how or where to ask for help. And when they do seek help, they often find little information available about which treatments are likely to work best for an individual patient.” Click here to view the blog post.
9. Upcoming Events and Webinar
ISPOR 20th Annual International MeetingMay 16 - 20, 2015, Philadelphia, PA Click here for details.Academy Health Webinar: Methodological Issues in Big Data Analytics May 7, 2015, 2:00 - 3:300 PM ET Click here for details.October 2015 CEPAC Meeting: Drug Therapies for High Cholesterol October 27, 2015, 10:00 AM - 4:00 PM EDT Click here for details.
North Carolina Translational & Clinical Sciences Institute: Bridges to Advance CER
May 13 - 14, 2015, Research Triangle Park, NC
Click here to register.
Mental Health Twitter Chat
May 19, 2015, 3:00 - 4:00 PM EDT
Join PCORI and others for a Twitter chat about how patient involvement in research is making a difference in mental health. Use #MHTalk to join the conversation.
PCORI Advisory Panel on Improving Healthcare Systems Spring 2015 Meeting
May 27 - 28, 2015
Click here for details.
PCORI Advisory Panel on Rare Disease Spring 2015 Meeting
May 27, 2015, 9:00 AM - 5:00 PM EDT
Click here for details.
Prioritizing Comparative Effectiveness Research Questions for Treatment of Major
Depressive Disorder: A Stakeholder Workshop
June 9, 2015,9:00 AM - 5:00 PM EDT
Click here for details.
Getting to Know PCORI: From Application to Closeout
June 22 - 23, 2015, Atlanta, GA
Click here for details.
11. AHRQ Effective Program Updates
Early Diagnosis, Prevention, and Treatment of C. difficile: Update, click here to comment by May 18.
Noninvasive Treatments for Low Back Pain, click here to comment by May 18.
Home-Based Primary Care Interventions, click here to comment by May 25.
Diabetes Medications for Adults with Type 2 Diabetes: An Update Focused on Monotherapy and Add-On Therapy to Metformin, click here to comment by June 1.
