In This Week’s Issue:
1. Save the Date December 5! PIPC Forum: Patient Voices, Patient Value – Developing Patient-Centered Solutions, see details below.
2. Sign and Share Petition to Give Patients and People Served by Health Systems a Voice in Healthcare, click here to view and sign the petition.
3. PCORI Annual Meeting and Patient Networking Reception, click here for more information.
4. PIPC Submits Comments on Proposed Changes to the National Health Interview Survey, click here to view the letter.
5. Healthcare Informatics: What Impact will Trump’s Victory Have on Value-Based Healthcare? Click here to view the article.
6. ICER Release of Evidence Report on Psoriasis and Request for Public Comment on Atopic Dermatitis Draft Scoping Document, click here to view the evidence report and click here to view the draft scoping document.
7. Viewpoint: Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS, click here to view the article.
8. The PCORI Blog: Changing the Course of Research, click here to view the blog post.
9. The PCORI Blog: When a Clinician Becomes a Patient, click here to view the blog post.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
1. Save the Date December 5! PIPC Forum: Patient Voices, Patient Value – Developing Patient-Centered Solutions, see details below.
2. Sign and Share Petition to Give Patients and People Served by Health Systems a Voice in Healthcare, click here to view and sign the petition.
3. PCORI Annual Meeting and Patient Networking Reception, click here for more information.
4. PIPC Submits Comments on Proposed Changes to the National Health Interview Survey, click here to view the letter.
5. Healthcare Informatics: What Impact will Trump’s Victory Have on Value-Based Healthcare? Click here to view the article.
6. ICER Release of Evidence Report on Psoriasis and Request for Public Comment on Atopic Dermatitis Draft Scoping Document, click here to view the evidence report and click here to view the draft scoping document.
7. Viewpoint: Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS, click here to view the article.
8. The PCORI Blog: Changing the Course of Research, click here to view the blog post.
9. The PCORI Blog: When a Clinician Becomes a Patient, click here to view the blog post.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
1. Save the Date Dec 5! PIPC Forum: Patient Voices, Patient Value – Developing Patient-Centered Solutions
As we make the transition to a value-based health care system, the importance of engagement with patients cannot be overstated. Yet we still face a pressing need for concrete actions and steps that can be taken to ensure patient voices are heard amidst the implementation of payment models seeking to achieve “value” in health care. Although the patient-centeredness movement has made significant strides over the last decade with the creation of the Patient-Centered Outcomes Research Institute (PCORI), the Food and Drug Administration’s (FDA) program for Patient-Focused Drug Development, and the Precision Medicine Initiative the patient-centeredness movement is at a crossroads, struggling whether to determine value of health care based on what is cost effective for the average patient or based on achieving outcomes that matter to individual patients and people with disabilities.
The 7th Annual PIPC Forum will highlight the ongoing efforts of organizations representing patients and people with disabilities to ensure all stakeholders are equipped with the tools they need to fully and meaningfully engage with patients and achieve value for the people served by health systems.
When:
Monday, December 5, 2016
12:00 p.m. – 2:00 p.m.
Where:
Reserve Officers Association
5th Floor Minuteman Ballroom
1 Constitution Ave NE, Washington, DC 20002
RSVP directly to [email protected]
2. Sign and Share Petition to Give Patients and People Served by Health Systems a Voice in Healthcare
Sign and share PIPC Chairman Tony Coelho’s recently launched petition calling on health care stakeholders to recognize patients and people served by health system’s movement for greater say in their own health care. “We urge both the media and politicians to take heed of what matters to us… because in the end, we are all patients,” Chairman Coelho writes.
Join the petition to all those who define your health care to say…
PIPC encourages every individual to sign and share the petition in order to increase its impact and raise awareness of the important issue. Click here to view and sign the petition.
3. PCORI Annual Meeting and Patient Networking Reception
The Patient-Centered Outcomes Research Institute (PCORI) is hosting its 2016 Annual Meeting entitled Changing the Conversation about Health Research this week, November 17-19 at the Gaylord National Resort and Convention Center in National Harbor, Maryland. They invite patients and caregivers to join more than 1,00 members of the healthcare community to hear updates on how scientists, patients, and other stakeholders are working together to make research more useful and relevant. Among those on Thursday’s panel (November 17) include PIPC Chairman Tony Coelho who will be speaking at 1:00pm and the National Alliance on Mental Illness’ (NAMI) Andrew Sperling, a PIPC Steering member, who will be speaking on the 3:30 PCORI panel on how patient needs and values can be made central to health research and decision making.
Click here for more information on PCORI’s Annual Meeting. PIPC is excited to be hosting a reception for participating patients during the annual meeting as well.
4. PIPC Submits Comments on Proposed Changes to the National Health Interview Survey
PIPC submitted comments last week on the review of the proposed changes to the National Health Interview Survey (NHIS). "PIPC supports the recommendations of the CCD Health Task Force urging the National Center for Health Statistics (NCHS) to include age of onset questions to help identify the adult population with developmental disabilities, especially considering the NCHS decision to stop asking the questions about specific conditions," PIPC writes. "We urge the NCHS to develop and test questions to identify adults with developmental disabilities. Otherwise, we urge you to reconsider asking about the specific conditions (intellectual disability, autism, cerebral palsy, epilepsy and others) and the age of onset so that the data continues to identify individuals with developmental disabilities."
“PIPC also shares the concerns of the CCD Health Task Force that the NHIS will include a variation of the six disability questions that are included in the American Community Survey (ACS). It is our understanding that HHS has adopted, at a minimum, the use of the six ACS questions to meet the ACA’s data collection responsibilities. We are concerned that varying the questions may affect the reliability and comparability of the data. We urge the NCHS to continue to include the six ACS disability questions and to specify how often they will be included in the survey.” Click here to view the letter.
5. Healthcare Informatics: What Impact will Trump’s Victory Have on Value-Based Healthcare?
Following the results of Tuesday’s Presidential Election, a Healthcare Informatics article speculates over what will occur in healthcare policy during the lame-duck session as well as into the Trump administration. In the analysis, the authors outline whether the election will have any likely impact on funding for the Patient-Centered Outcomes Research Institute (PCORI). “My sense is that the mission of PCORI is still very much recognized as being needed,” says Tom Leary, Healthcare Information and Management Systems Society (HIMMS) vice president of government relations. “The mission around patient-centered outcomes research, and outcomes research in general and its funding has been a bipartisan initiative since the 2003 Medical Improvement Act. It was the Bush administration and Republican Congress that got us started down that road of using outcomes research. So I think the idea of outcomes research helping to improve where we spend our precious healthcare resources will continue to be an important initiative funded by the government and by the private sector.” Click here to view the article.
6. ICER Release of Evidence Report on Psoriasis and Request for Public Comment on Atopic Dermatitis Draft Scoping Document
Last week, the Institute for Clinical and Economic Review (ICER) released an Evidence Report on the comparative clinical effectiveness and value of targeted immunomodulators for adults with moderate-to-severe plaque psoriasis. National Psoriasis Foundation (NPF) has remained actively engaged with ICER on the agencies’ psoriasis work. The foundation expressed a number of concerns during public comment on the agency’s September 29 draft evidence report, including that it contained many gaping omissions, assumptions, and value conclusions that challenge the report findings, incorrectly characterized psoriasis and patient perspectives without accounting for the heterogeneity of the disease, and that the ICER cost model lacked transparency and acknowledgement of variability between payers and over time. The final report’s conclusions shifted considerably from the draft report. The New England Comparative Effectiveness Public Advisory Council (New England CEPAC), a core program of ICER, will deliberate and vote on evidence presented in ICER's report on treatments for psoriasis at Harvard Medical School on November 18, 2016. NPF and others will be in attendance at this meeting offering oral public comment and contributing to the policy roundtable taking place as part of the meeting.
Meanwhile, ICER also released a request for public comment on their Draft Scoping Document on atopic dermatitis. Notably, the Asthma Allergy Foundation of America (AAFA) is among their list of key stakeholders for public comment.
7. Viewpoint: Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS
In an article published in the Journal of the American Medical Association (JAMA), Drs. Robert Califf and Rachel Sherman of the Food and Drug Administration (FDA), and Andy Slavitt of the Centers for Medicare and Medicaid Services (CMS) discuss the agencies’ roles in evaluating and approving prescription drugs. The leaders of the two agencies highlight the unintended results of limitations arising from the separate evolution of clinical and research environments and the “absence of a means for efficient data exchange between these 2 spheres were trials that often do not adequately inform practice and product labeling that sometimes lacks optimal empirical information to guide use of the product in clinical practice.” The authors state, “It is imperative that the US regulatory groups bridge this gap between evidence that is generated through trials performed primarily to obtain marketing approval for drugs and high-risk devices and the optimal kinds of evidence needed to support the intended uses of these products in practice.”
Califf, Sherman, and Slavitt go on to express the need to ensure that patients, clinicians, and payers have adequate evidence to guide their choices, and outline a number of ways that the FDA and CMS are following these approaches. Notably, they highlight the fact that this effort will require broad collaboration across public and private sectors. “The Patient-Centered Outcomes Research Institute, which is overseen by a board representing key stakeholders (including the medical products industry), is one example of an entity designed to develop this knowledge,” they write. “It will be particularly important for clinicians, professional societies, and health systems to engage in developing effective approaches to integrating broader evidence generation with practice.” Click here to view the article.
8. The PCORI Blog: Changing the Course of Research
Laura Anthony of the Children’s National Health System describes the clinic’s PCORI-funded project to help low-income children who have autism spectrum disorders or attention-deficit hyperactivity disorder (ADHD). She noted that members of the project went out to schools and introduced two interventions for kids with autism spectrum disorders or ADHD. One, called Unstuck and On Target (UOT), teaches children to use specific scripts to help them stay flexible, make better plans, and improve behavior. The other, Contingency Behavioral Management, emphasizes positive rewards for good behavior, including flexibility.
When asked how PCORI-funded studies like hers are changing the conversation, Ms. Anthony replied, “When PCORI launched, it really opened the treatment-research world to new possibilities. PCORI has effected fundamental change in the society of researchers. As opposed to even five or seven years ago, most people are now talking about inclusion of stakeholders. PCORI has had an effect on the culture of research that is really invaluable. And more and more patient groups are feeling empowered and asking to partner in research. That’s just making our jobs easier and our findings better and more relevant.” Click here to view the blog post.
9. The PCORI Blog: When a Clinician Becomes a Patient
In anticipation of PCORI’s second Annual Meeting, November 17-19, the agency asked several of the scheduled presenters to describe their journey into patient-centered outcomes research and discuss what the meeting’s theme, “Changing the Conversation about Health Research,” means to them. One presenter describes her experiences being diagnosed and living with multiple sclerosis (MS) in the blog post. She explains that she now uses her MS experiences to help others and details her participation in research efforts such as IConquerMS. “We are working to enroll people with MS into the initiative, build trust within the MS community, and take advantage of PCORnet’s unique way of doing research,” she writes. “Joining iConquerMS has been incredibly empowering. It gives people with MS some of the power and control that MS takes from us. Being a member of iConquerMS gives me hope because I know that I am helping create a brighter future for myself and my patients.” Click here to view the blog post.
10. Upcoming Events and Webinars
Health Systems and Addiction: The Use and Misuse of Legal Substances
November 16 - 17, 2016, National Academy of Sciences, Washington, DC
Click here for details.
2016 PCORI Annual Meeting
November 17 - 19, 2016, Gaylord National Resort & Convention Center, National Harbor, MD
Click here for details.
Cancer Support Community: Access to Care in Cancer 2016
November 30, 2016, 9:00AM – 12:00pm
Click here for details.
Recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine
December 7, 2016, 9:00AM - 4:30PM
Click here for details.
2017 National Health Policy Conference
January 30 - 31, 2017, Marriott, Marquis, Washington D.C.
Click here for details.
11. Medical Journal Articles
From Concept to Policy: 10 Years After the Call for a US Center for Comparative Effectiveness Information, click here to view.
12. AHRQ Effective Program Updates
Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents, click here to view.
Patient Safety in Ambulatory Settings -- Final Report, click here to view.
As we make the transition to a value-based health care system, the importance of engagement with patients cannot be overstated. Yet we still face a pressing need for concrete actions and steps that can be taken to ensure patient voices are heard amidst the implementation of payment models seeking to achieve “value” in health care. Although the patient-centeredness movement has made significant strides over the last decade with the creation of the Patient-Centered Outcomes Research Institute (PCORI), the Food and Drug Administration’s (FDA) program for Patient-Focused Drug Development, and the Precision Medicine Initiative the patient-centeredness movement is at a crossroads, struggling whether to determine value of health care based on what is cost effective for the average patient or based on achieving outcomes that matter to individual patients and people with disabilities.
The 7th Annual PIPC Forum will highlight the ongoing efforts of organizations representing patients and people with disabilities to ensure all stakeholders are equipped with the tools they need to fully and meaningfully engage with patients and achieve value for the people served by health systems.
When:
Monday, December 5, 2016
12:00 p.m. – 2:00 p.m.
Where:
Reserve Officers Association
5th Floor Minuteman Ballroom
1 Constitution Ave NE, Washington, DC 20002
RSVP directly to [email protected]
2. Sign and Share Petition to Give Patients and People Served by Health Systems a Voice in Healthcare
Sign and share PIPC Chairman Tony Coelho’s recently launched petition calling on health care stakeholders to recognize patients and people served by health system’s movement for greater say in their own health care. “We urge both the media and politicians to take heed of what matters to us… because in the end, we are all patients,” Chairman Coelho writes.
Join the petition to all those who define your health care to say…
- We insist that on engaging patients, caregivers, and people living with incurable diseases or lifelong disabilities in health care decision-making.
- We want to be at the center of health care.
- We want policies to explicitly empower consumers, patients and providers.
- We want to know what decisions about our health are being made by the government.
- We want a health care system that rewards the outcomes that matter to us as patients and participants in this nation’s health system.
- We reject the notion that we should be bundled into one-size-fits-all care models, or valued against one-size-fits-all judgments of cost-effectiveness. Don’t tell us what we’re worth – ask us what we value.
- None of us is average. We are unique individuals with different genetics, characteristics, needs and preferences. Especially in this promising new age of personalized medicine, we are confounded by proposals in vital programs like Medicare that aim to eliminate, rather than empower, choice of treatments.
PIPC encourages every individual to sign and share the petition in order to increase its impact and raise awareness of the important issue. Click here to view and sign the petition.
3. PCORI Annual Meeting and Patient Networking Reception
The Patient-Centered Outcomes Research Institute (PCORI) is hosting its 2016 Annual Meeting entitled Changing the Conversation about Health Research this week, November 17-19 at the Gaylord National Resort and Convention Center in National Harbor, Maryland. They invite patients and caregivers to join more than 1,00 members of the healthcare community to hear updates on how scientists, patients, and other stakeholders are working together to make research more useful and relevant. Among those on Thursday’s panel (November 17) include PIPC Chairman Tony Coelho who will be speaking at 1:00pm and the National Alliance on Mental Illness’ (NAMI) Andrew Sperling, a PIPC Steering member, who will be speaking on the 3:30 PCORI panel on how patient needs and values can be made central to health research and decision making.
Click here for more information on PCORI’s Annual Meeting. PIPC is excited to be hosting a reception for participating patients during the annual meeting as well.
4. PIPC Submits Comments on Proposed Changes to the National Health Interview Survey
PIPC submitted comments last week on the review of the proposed changes to the National Health Interview Survey (NHIS). "PIPC supports the recommendations of the CCD Health Task Force urging the National Center for Health Statistics (NCHS) to include age of onset questions to help identify the adult population with developmental disabilities, especially considering the NCHS decision to stop asking the questions about specific conditions," PIPC writes. "We urge the NCHS to develop and test questions to identify adults with developmental disabilities. Otherwise, we urge you to reconsider asking about the specific conditions (intellectual disability, autism, cerebral palsy, epilepsy and others) and the age of onset so that the data continues to identify individuals with developmental disabilities."
“PIPC also shares the concerns of the CCD Health Task Force that the NHIS will include a variation of the six disability questions that are included in the American Community Survey (ACS). It is our understanding that HHS has adopted, at a minimum, the use of the six ACS questions to meet the ACA’s data collection responsibilities. We are concerned that varying the questions may affect the reliability and comparability of the data. We urge the NCHS to continue to include the six ACS disability questions and to specify how often they will be included in the survey.” Click here to view the letter.
5. Healthcare Informatics: What Impact will Trump’s Victory Have on Value-Based Healthcare?
Following the results of Tuesday’s Presidential Election, a Healthcare Informatics article speculates over what will occur in healthcare policy during the lame-duck session as well as into the Trump administration. In the analysis, the authors outline whether the election will have any likely impact on funding for the Patient-Centered Outcomes Research Institute (PCORI). “My sense is that the mission of PCORI is still very much recognized as being needed,” says Tom Leary, Healthcare Information and Management Systems Society (HIMMS) vice president of government relations. “The mission around patient-centered outcomes research, and outcomes research in general and its funding has been a bipartisan initiative since the 2003 Medical Improvement Act. It was the Bush administration and Republican Congress that got us started down that road of using outcomes research. So I think the idea of outcomes research helping to improve where we spend our precious healthcare resources will continue to be an important initiative funded by the government and by the private sector.” Click here to view the article.
6. ICER Release of Evidence Report on Psoriasis and Request for Public Comment on Atopic Dermatitis Draft Scoping Document
Last week, the Institute for Clinical and Economic Review (ICER) released an Evidence Report on the comparative clinical effectiveness and value of targeted immunomodulators for adults with moderate-to-severe plaque psoriasis. National Psoriasis Foundation (NPF) has remained actively engaged with ICER on the agencies’ psoriasis work. The foundation expressed a number of concerns during public comment on the agency’s September 29 draft evidence report, including that it contained many gaping omissions, assumptions, and value conclusions that challenge the report findings, incorrectly characterized psoriasis and patient perspectives without accounting for the heterogeneity of the disease, and that the ICER cost model lacked transparency and acknowledgement of variability between payers and over time. The final report’s conclusions shifted considerably from the draft report. The New England Comparative Effectiveness Public Advisory Council (New England CEPAC), a core program of ICER, will deliberate and vote on evidence presented in ICER's report on treatments for psoriasis at Harvard Medical School on November 18, 2016. NPF and others will be in attendance at this meeting offering oral public comment and contributing to the policy roundtable taking place as part of the meeting.
Meanwhile, ICER also released a request for public comment on their Draft Scoping Document on atopic dermatitis. Notably, the Asthma Allergy Foundation of America (AAFA) is among their list of key stakeholders for public comment.
7. Viewpoint: Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS
In an article published in the Journal of the American Medical Association (JAMA), Drs. Robert Califf and Rachel Sherman of the Food and Drug Administration (FDA), and Andy Slavitt of the Centers for Medicare and Medicaid Services (CMS) discuss the agencies’ roles in evaluating and approving prescription drugs. The leaders of the two agencies highlight the unintended results of limitations arising from the separate evolution of clinical and research environments and the “absence of a means for efficient data exchange between these 2 spheres were trials that often do not adequately inform practice and product labeling that sometimes lacks optimal empirical information to guide use of the product in clinical practice.” The authors state, “It is imperative that the US regulatory groups bridge this gap between evidence that is generated through trials performed primarily to obtain marketing approval for drugs and high-risk devices and the optimal kinds of evidence needed to support the intended uses of these products in practice.”
Califf, Sherman, and Slavitt go on to express the need to ensure that patients, clinicians, and payers have adequate evidence to guide their choices, and outline a number of ways that the FDA and CMS are following these approaches. Notably, they highlight the fact that this effort will require broad collaboration across public and private sectors. “The Patient-Centered Outcomes Research Institute, which is overseen by a board representing key stakeholders (including the medical products industry), is one example of an entity designed to develop this knowledge,” they write. “It will be particularly important for clinicians, professional societies, and health systems to engage in developing effective approaches to integrating broader evidence generation with practice.” Click here to view the article.
8. The PCORI Blog: Changing the Course of Research
Laura Anthony of the Children’s National Health System describes the clinic’s PCORI-funded project to help low-income children who have autism spectrum disorders or attention-deficit hyperactivity disorder (ADHD). She noted that members of the project went out to schools and introduced two interventions for kids with autism spectrum disorders or ADHD. One, called Unstuck and On Target (UOT), teaches children to use specific scripts to help them stay flexible, make better plans, and improve behavior. The other, Contingency Behavioral Management, emphasizes positive rewards for good behavior, including flexibility.
When asked how PCORI-funded studies like hers are changing the conversation, Ms. Anthony replied, “When PCORI launched, it really opened the treatment-research world to new possibilities. PCORI has effected fundamental change in the society of researchers. As opposed to even five or seven years ago, most people are now talking about inclusion of stakeholders. PCORI has had an effect on the culture of research that is really invaluable. And more and more patient groups are feeling empowered and asking to partner in research. That’s just making our jobs easier and our findings better and more relevant.” Click here to view the blog post.
9. The PCORI Blog: When a Clinician Becomes a Patient
In anticipation of PCORI’s second Annual Meeting, November 17-19, the agency asked several of the scheduled presenters to describe their journey into patient-centered outcomes research and discuss what the meeting’s theme, “Changing the Conversation about Health Research,” means to them. One presenter describes her experiences being diagnosed and living with multiple sclerosis (MS) in the blog post. She explains that she now uses her MS experiences to help others and details her participation in research efforts such as IConquerMS. “We are working to enroll people with MS into the initiative, build trust within the MS community, and take advantage of PCORnet’s unique way of doing research,” she writes. “Joining iConquerMS has been incredibly empowering. It gives people with MS some of the power and control that MS takes from us. Being a member of iConquerMS gives me hope because I know that I am helping create a brighter future for myself and my patients.” Click here to view the blog post.
10. Upcoming Events and Webinars
Health Systems and Addiction: The Use and Misuse of Legal Substances
November 16 - 17, 2016, National Academy of Sciences, Washington, DC
Click here for details.
2016 PCORI Annual Meeting
November 17 - 19, 2016, Gaylord National Resort & Convention Center, National Harbor, MD
Click here for details.
Cancer Support Community: Access to Care in Cancer 2016
November 30, 2016, 9:00AM – 12:00pm
Click here for details.
Recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine
December 7, 2016, 9:00AM - 4:30PM
Click here for details.
2017 National Health Policy Conference
January 30 - 31, 2017, Marriott, Marquis, Washington D.C.
Click here for details.
11. Medical Journal Articles
From Concept to Policy: 10 Years After the Call for a US Center for Comparative Effectiveness Information, click here to view.
12. AHRQ Effective Program Updates
Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents, click here to view.
Patient Safety in Ambulatory Settings -- Final Report, click here to view.
