In This Week’s Issue:
- PIPC Submits Comments to CMS on MACRA, APMs, click here to view the letter.
- PIPC Roundtable Summary and Recommendations: Assessing Value to the Patient, click here to view a summary.
- Patient Advocates Upset By Value-Based Assessments In Part B Drug Pay Demo, clickhere to view the full article (subscription only).
- Wilcox: Healthcare’s War on Costs Is Really a War on Patients, click here to view the article.
- Expanding the Role of Patients in Setting Research Priorities, click here to view the article.
- AHRQ Dissemination and Implementation Initiative Demonstrates Ongoing Importance of PCOR, click here to view the blog post.
- Video: Limitations of ICER's Value Assessment Framework Tool, click here to view the video.
1. PIPC Submits Comments to CMS on MACRA, AMPs
Today, the Partnership to Improve Patient Care (PIPC) submitted comments on the implementation of the Merit-based Incentive Payment System (MIPS), Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models passed as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Since its founding, PIPC has been at the forefront of patient-centeredness in comparative effectiveness research (CER) – both its generation at the Patient-Centered Outcomes Research Institute (PCORI), and its translation into patient care.
Among the highlights of PIPC's comments to CMS:
2. PIPC Roundtable Summary and Recommendations: Assessing Value to the Patient
For the past several years, there has been a shift to a health care system based on value, rather than volume. Amidst this shift, “value to whom” has been a consistent question, with payers, providers, patients and other stakeholders defining “value” from different vantage points. PIPC has continuously advocated that value should first and foremost be considered through the lens of patients and people with disabilities who are the ultimate beneficiaries of health care.
PIPC convened a roundtable on May 6, 2016, because we are very concerned that payers, physicians and policymakers are increasingly using value frameworks in the private sector – and potentially in the public sector – to determine patient access. Many emerging value frameworks are driven by payers, represent the ideals of payers, and are therefore representative of their goal to reduce costs. Although labeled as “value frameworks,” many of these frameworks do not accurately capture what patients value. In fact, they often are in conflict with stakeholder efforts to move towards a more patient-centric health care system and advance access to personalized and precision medicine.
The shortcomings of status quo value frameworks and tools and potential considerations for improving their patient-centeredness were summarized as follows:
To impact the status quo development of value frameworks and tools, participants agreed to the following next steps:
Click here to view a summary of the roundtable.
3. Patient Advocates Upset By Value-Based Assessments In Part B Drug Pay Demo
In a feature article last week, Inside Health Policy reported that “patient advocacy groups are raising concerns with the proposed use of value-based assessments in the second phase of the controversial Part B drug pay demo, as one cancer patient advocate said a number of value-assessment frameworks for drugs are devoid of patients’ voices and others say there is a lack of disease-specific expertise on panels like ICER that vote on the value of a drug for patients. Advocates for patients with cancer, liver disease, mental health and other conditions said CMS’ move to, as part of the demonstration, use value-assessment frameworks -- which focus on the value of a drug to the average patient -- goes against the agency’s focus on personalized medicine.”
“… [CMS’] proposed rule indicates that ICER reports would play a role in determining clinical effectiveness for drugs as part of the test of reference pricing. Donna Cryer, president and CEO of the Global Liver Institute, said that if CMS is going to move forward with using some form of value-based framework as part of the demonstration, picking ICER is problematic. Cryer said the institute has little engagement with patient groups, and it is often difficult for patient groups that want to provide feedback to ICER to do so. Robin Tuohy, senior director of support groups for the International Myeloma Foundation, said that ICER does not have enough disease-specific expertise when making assessments on the value of a drug. Patient advocates also raised concerns with ICER’s methodology. If the agency continues to focus on value-based frameworks as part of the demonstration, it should at least use one that signals it values patients and includes a number of experts as part of its decision making, Cryer said.”
“Patricia Goldsmith, chief executive officer of CancerCare, said there is a proliferation of value-based frameworks that are devoid of patient voices. These frameworks, she said, tend to focus on short-term costs, not the full spectrum of treatment. Goldsmith and Andrew Sperling, director of legislative advocacy for the National Alliance on Mental Illness, said using value-based frameworks would be at odds with CMS’ goals on personalized medicine since the frameworks focus on value for the average patient. Goldsmith, however, said she was hopeful following a recent meeting with CMS Acting Administrator Andrew Slavitt and CMS Deputy Administrator Patrick Conway where she raised concerns with the second phase of the demonstration. She added that CMS wants to engage with patients.” Click here to view the full article (subscription only).
4. Wilcox: Healthcare’s War on Costs Is Really a War on Patients
In a recent opinion piece, Jonathan Wilcox of Patients Rising discusses “a little-known – and increasingly influential – national non-profit called the Institute for Clinical and Economic Review.” As he explains, “ICER, as it is known, is quietly working to develop pseudo-scientific analyses that will effectively function as price controls. The group, which works closely with the health-insurance industry, recently unveiled one such analysis, which it calls a ‘value framework.’ If you haven’t heard of a “value framework” before, you’re not alone. They’re complicated mathematical calculations that dictate the rationing of medicines that are supposedly too costly. If a patient’s treatment crosses a certain financial threshold, the framework determines that further treatment is financially unwarranted… Consider the value framework ICER recently unveiled for multiple myeloma, a rare form of blood cancer. It estimates that every year of a sick patient’s life is worth as little as 3/5 of a year for a healthy person. It won’t matter what your doctors say or if there’s a drug that could help you — if the formula says it’s too expensive, you’re done. Think for a moment how Stephen Hawking or Magic Johnson would fare in a system that judged their value in this way.” Click here to view the article.
5. Expanding the Role of Patients in Setting Research Priorities
As reported last week in MD News, “One [2015 PCORI] research study examined the impact of a blood thinner on outcomes among stroke survivors after they left the hospital,’ [Jean Slutsky, Chief Engagement and Dissemination Officer, PCORI] says. ‘A traditional study might have focused only on whether patients had another stroke or side effects like bleeding — important questions, to be sure. But in this study, researchers had asked patients what outcome was most important to them and learned that they cared most about how long they could live at home without suffering complications requiring additional hospital or nursing home care.” Click here to view the article.
6. AHRQ Dissemination and Implementation Initiative Demonstrates Ongoing Importance of PCOR
In a post for the AHRQ Blog, the agency’s Deputy Director Sharon B. Arnold, Ph.D notes that “AHRQ was an early pioneer of research comparing the effectiveness of different health care approaches... At AHRQ, our focus has shifted from funding this work to disseminating and implementing PCOR findings... That's why I'm so excited to announce a new AHRQ PCOR Dissemination and Implementation (D&I) Initiative. It takes findings with proven benefits and shares them directly with the field—where patients and providers need them most.” Click here to view the blog post.
7. Video: Limitations of ICER's Value Assessment Framework Tool
In a video published by The American Journal of Managed Care, Alan Balch, PhD, discusses the Institute for Clinical and Economic Review (ICER)'s Value Assessment Framework tool that aims to provide stakeholders in healthcare with evidence to make more informed decisions regarding new cancer therapies. Dr. Balch also considers limitations to the tool's effectiveness.” Click here to view the video.
Today, the Partnership to Improve Patient Care (PIPC) submitted comments on the implementation of the Merit-based Incentive Payment System (MIPS), Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models passed as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Since its founding, PIPC has been at the forefront of patient-centeredness in comparative effectiveness research (CER) – both its generation at the Patient-Centered Outcomes Research Institute (PCORI), and its translation into patient care.
Among the highlights of PIPC's comments to CMS:
- Patient Advisory Panel – A broad Patient Advisory Panel within CMMI would be a first step to ensure new payment models are aligned with care that patients’ value. A Patient Advisory Panel could provide guidance to CMMI in identifying the key areas that would benefit from patient input, including APM development, model design features that will promote effective patient engagement, and metrics (e.g., patient-centered quality measures and other tools) on which to assess the success of these efforts.
- Direct Outreach to Patients – Achieving meaningful input from beneficiary stakeholders, particularly patients, people with disabilities, and their families, is a continuous process that requires targeted strategies in addition to regulatory notice and comment. This means conducting outreach to subgroups of organizations representing patients and people with disabilities that are directly impacted at the outset to determine what innovative models may be needed to improve care for particular patient populations.
- Measure Outcomes that Matter to Patients – To promote patient-centered care, payment systems must have incentives to capture patient preferences and to demonstrate those preferences are driving care decisions. At the same time, it is important to prioritize the measures to which providers are held accountable so that they truly reflect outcomes that matter patients and do not place undue administrative burdens on providers.
- Be Accountable for Patient Input – As part of the process for obtaining public input, CMS and CMMI should note where they have incorporated stakeholder feedback in the final framework of a demonstration program, and provide a rationale for instances in which stakeholder feedback has not been accepted, similar to the current requirements in place for notice-and-comment rulemaking.
- Advance Shared Decision-Making – PIPC urges policymakers not to lose focus on the building blocks for patient-centered health care incorporated into the early phases of evidence development, translation and implementation, all the way through to the design and implementation of new payment and delivery reform models. In this way, our health care system will be built to improve health outcomes by identifying the treatments that work best for individual patients.
2. PIPC Roundtable Summary and Recommendations: Assessing Value to the Patient
For the past several years, there has been a shift to a health care system based on value, rather than volume. Amidst this shift, “value to whom” has been a consistent question, with payers, providers, patients and other stakeholders defining “value” from different vantage points. PIPC has continuously advocated that value should first and foremost be considered through the lens of patients and people with disabilities who are the ultimate beneficiaries of health care.
PIPC convened a roundtable on May 6, 2016, because we are very concerned that payers, physicians and policymakers are increasingly using value frameworks in the private sector – and potentially in the public sector – to determine patient access. Many emerging value frameworks are driven by payers, represent the ideals of payers, and are therefore representative of their goal to reduce costs. Although labeled as “value frameworks,” many of these frameworks do not accurately capture what patients value. In fact, they often are in conflict with stakeholder efforts to move towards a more patient-centric health care system and advance access to personalized and precision medicine.
The shortcomings of status quo value frameworks and tools and potential considerations for improving their patient-centeredness were summarized as follows:
- Value Framework’s Focus on Cost Effectiveness Limits Their Use by Patients & Providers
- Value Frameworks Are Limited by Focus on Randomized Clinical Trials (RTC) Data
- Value Frameworks Lack Transparency
- Value Framework Developers Often Fail to Engage Patients and People with Disabilities
- Lack of Consensus on Assumptions, Definitions and Questions
- Fail to Reflect Outcomes that Matter to Patients and People with Disabilities
- Produces a Single Universal Score or Value
- Use of Quality Adjusted Life Years (QALYs) Disadvantages People with Disabilities
- Focus is on Cost to Society, Not Costs that Matter to Patients
To impact the status quo development of value frameworks and tools, participants agreed to the following next steps:
- Advocate for Use of the National Health Council’s Patient-Centered Value Model Rubric
- Train Advocates to participate and comment on the development of value frameworks and tools.
- Engage Providers to ensure that value assessment frameworks do not conflict with making treatment decisions that are right for individual patients.
- Engage Payers and encourage them engage with patients and people with disabilities in a conversation about how value frameworks are developed and used.
- Engage Policymakers to discourage the endorsement and use of existing value frameworks and tools in public policy.
- Engage Purchasers who recognize the benefits of increased productivity and overall well-being, thereby increasing employee retention.
- Create Multiple “Disruptive” Alternative tools that Capture Value to Patients
Click here to view a summary of the roundtable.
3. Patient Advocates Upset By Value-Based Assessments In Part B Drug Pay Demo
In a feature article last week, Inside Health Policy reported that “patient advocacy groups are raising concerns with the proposed use of value-based assessments in the second phase of the controversial Part B drug pay demo, as one cancer patient advocate said a number of value-assessment frameworks for drugs are devoid of patients’ voices and others say there is a lack of disease-specific expertise on panels like ICER that vote on the value of a drug for patients. Advocates for patients with cancer, liver disease, mental health and other conditions said CMS’ move to, as part of the demonstration, use value-assessment frameworks -- which focus on the value of a drug to the average patient -- goes against the agency’s focus on personalized medicine.”
“… [CMS’] proposed rule indicates that ICER reports would play a role in determining clinical effectiveness for drugs as part of the test of reference pricing. Donna Cryer, president and CEO of the Global Liver Institute, said that if CMS is going to move forward with using some form of value-based framework as part of the demonstration, picking ICER is problematic. Cryer said the institute has little engagement with patient groups, and it is often difficult for patient groups that want to provide feedback to ICER to do so. Robin Tuohy, senior director of support groups for the International Myeloma Foundation, said that ICER does not have enough disease-specific expertise when making assessments on the value of a drug. Patient advocates also raised concerns with ICER’s methodology. If the agency continues to focus on value-based frameworks as part of the demonstration, it should at least use one that signals it values patients and includes a number of experts as part of its decision making, Cryer said.”
“Patricia Goldsmith, chief executive officer of CancerCare, said there is a proliferation of value-based frameworks that are devoid of patient voices. These frameworks, she said, tend to focus on short-term costs, not the full spectrum of treatment. Goldsmith and Andrew Sperling, director of legislative advocacy for the National Alliance on Mental Illness, said using value-based frameworks would be at odds with CMS’ goals on personalized medicine since the frameworks focus on value for the average patient. Goldsmith, however, said she was hopeful following a recent meeting with CMS Acting Administrator Andrew Slavitt and CMS Deputy Administrator Patrick Conway where she raised concerns with the second phase of the demonstration. She added that CMS wants to engage with patients.” Click here to view the full article (subscription only).
4. Wilcox: Healthcare’s War on Costs Is Really a War on Patients
In a recent opinion piece, Jonathan Wilcox of Patients Rising discusses “a little-known – and increasingly influential – national non-profit called the Institute for Clinical and Economic Review.” As he explains, “ICER, as it is known, is quietly working to develop pseudo-scientific analyses that will effectively function as price controls. The group, which works closely with the health-insurance industry, recently unveiled one such analysis, which it calls a ‘value framework.’ If you haven’t heard of a “value framework” before, you’re not alone. They’re complicated mathematical calculations that dictate the rationing of medicines that are supposedly too costly. If a patient’s treatment crosses a certain financial threshold, the framework determines that further treatment is financially unwarranted… Consider the value framework ICER recently unveiled for multiple myeloma, a rare form of blood cancer. It estimates that every year of a sick patient’s life is worth as little as 3/5 of a year for a healthy person. It won’t matter what your doctors say or if there’s a drug that could help you — if the formula says it’s too expensive, you’re done. Think for a moment how Stephen Hawking or Magic Johnson would fare in a system that judged their value in this way.” Click here to view the article.
5. Expanding the Role of Patients in Setting Research Priorities
As reported last week in MD News, “One [2015 PCORI] research study examined the impact of a blood thinner on outcomes among stroke survivors after they left the hospital,’ [Jean Slutsky, Chief Engagement and Dissemination Officer, PCORI] says. ‘A traditional study might have focused only on whether patients had another stroke or side effects like bleeding — important questions, to be sure. But in this study, researchers had asked patients what outcome was most important to them and learned that they cared most about how long they could live at home without suffering complications requiring additional hospital or nursing home care.” Click here to view the article.
6. AHRQ Dissemination and Implementation Initiative Demonstrates Ongoing Importance of PCOR
In a post for the AHRQ Blog, the agency’s Deputy Director Sharon B. Arnold, Ph.D notes that “AHRQ was an early pioneer of research comparing the effectiveness of different health care approaches... At AHRQ, our focus has shifted from funding this work to disseminating and implementing PCOR findings... That's why I'm so excited to announce a new AHRQ PCOR Dissemination and Implementation (D&I) Initiative. It takes findings with proven benefits and shares them directly with the field—where patients and providers need them most.” Click here to view the blog post.
7. Video: Limitations of ICER's Value Assessment Framework Tool
In a video published by The American Journal of Managed Care, Alan Balch, PhD, discusses the Institute for Clinical and Economic Review (ICER)'s Value Assessment Framework tool that aims to provide stakeholders in healthcare with evidence to make more informed decisions regarding new cancer therapies. Dr. Balch also considers limitations to the tool's effectiveness.” Click here to view the video.
