In This Week’s Issue:
- 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).
- Coalition for Better Care Seeking Signatures on MACRA Comments Today, click hereto view the letter.
- ICER Under Scrutiny for Ties to Insurance Industry, click here to view the article.
- ‘Patients Are the Real Experts': DO Wraps Up $1.2 Million PCORI Project, click here to view the article.
1. 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.
2. 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).
3. Coalition for Better Care Seeking Signatures on MACRA Comments Today
The Coalition for Better Care is seeking signatures on a letter providing comments on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) providing recommendations to meet the need for consumer and patient involvement in the development of the underlying models categorized as Advanced Alternative Payment Models (APMs); requiring use of a clinical care model for all Advanced APMs; and ensuring consumer safeguards keep pace with risk-based APMs. The full letter may be viewed here. Contact Susan Glover ([email protected]) by 2pm to sign on.
4. ICER Under Scrutiny for Ties to Insurance Industry
As reported in The Hill last week, “the Biotechnology Innovation Organization (BIO) is accusing insurance companies of funneling cash into a little-known outside group that recommends its own drug prices with hopes of driving down overall costs. The decade-old group, called the Institute of Clinical and Economic Review (ICER), has been hailed as a ‘Consumer Reports’ for prescription drugs and is one of the only sources of drug data available to the public… But in recent weeks, organizations like BIO have called for more scrutiny into the independent group’s ties to the insurance industry. In a debate playing out through online op-eds, critics say insurers are trying to ‘shirk their responsibility’ to pay for pricier drugs that are more effective.
“ICER has almost no name recognition beyond a small circle of drug, insurer and patient advocacy representatives deep in the policy world. The group recently morphed from an academic research group into an official nonprofit. Pearson said for most of the group’s history, it focused far more on medical devices and procedures than drugs. But he said there’s been a shift in the last several years as public concerns about affordability began to mount. Greenwood, who has led BIO since 2005, said he’s become ‘very concerned’ that ICER is increasingly wading into drug pricing, especially as federal and state health agencies are now eying the analyses. The Centers for Medicare and Medicaid Services said for the first time this year that it could start using ICER’s analysis in a controversial program change that would cut Medicare Part B reimbursement rates to help focus on drugs with the most value.”
“Some in the drug lobby have also pointed to ICER’s history in the insurance industry. Pearson, the founder, was a former senior fellow with America’s Health Insurers of America. Several members of its board are also currently at companies including UnitedHealth Group and Blue Cross Blue Shield of California. The group also receives about 10 percent of its funding from insurance companies, according to its website.” Click here to view the article.
5. ‘Patients Are the Real Experts': DO Wraps Up $1.2 Million PCORI Project
Laura Selby of The DO reports, “Dr. Swigris is the principal investigator for a three-year, $1.2 million PCORI-funded project on how using supplemental oxygen affects quality of life for patients with pulmonary fibrosis. The project kicked off in August 2013 and will stop collecting data on patients, who were tracked for one year each, later this month...For other DOs who'd like to pursue research funding through PCORI, Dr. Swigris's advice is simple: Talk to patients. ‘Patients are the real experts on their disease,’ he says. ‘If you can marry your clinical interests with their wishes and needs, that provides a great setup for a study.’” Click here to view the article.
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.
2. 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).
3. Coalition for Better Care Seeking Signatures on MACRA Comments Today
The Coalition for Better Care is seeking signatures on a letter providing comments on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) providing recommendations to meet the need for consumer and patient involvement in the development of the underlying models categorized as Advanced Alternative Payment Models (APMs); requiring use of a clinical care model for all Advanced APMs; and ensuring consumer safeguards keep pace with risk-based APMs. The full letter may be viewed here. Contact Susan Glover ([email protected]) by 2pm to sign on.
4. ICER Under Scrutiny for Ties to Insurance Industry
As reported in The Hill last week, “the Biotechnology Innovation Organization (BIO) is accusing insurance companies of funneling cash into a little-known outside group that recommends its own drug prices with hopes of driving down overall costs. The decade-old group, called the Institute of Clinical and Economic Review (ICER), has been hailed as a ‘Consumer Reports’ for prescription drugs and is one of the only sources of drug data available to the public… But in recent weeks, organizations like BIO have called for more scrutiny into the independent group’s ties to the insurance industry. In a debate playing out through online op-eds, critics say insurers are trying to ‘shirk their responsibility’ to pay for pricier drugs that are more effective.
“ICER has almost no name recognition beyond a small circle of drug, insurer and patient advocacy representatives deep in the policy world. The group recently morphed from an academic research group into an official nonprofit. Pearson said for most of the group’s history, it focused far more on medical devices and procedures than drugs. But he said there’s been a shift in the last several years as public concerns about affordability began to mount. Greenwood, who has led BIO since 2005, said he’s become ‘very concerned’ that ICER is increasingly wading into drug pricing, especially as federal and state health agencies are now eying the analyses. The Centers for Medicare and Medicaid Services said for the first time this year that it could start using ICER’s analysis in a controversial program change that would cut Medicare Part B reimbursement rates to help focus on drugs with the most value.”
“Some in the drug lobby have also pointed to ICER’s history in the insurance industry. Pearson, the founder, was a former senior fellow with America’s Health Insurers of America. Several members of its board are also currently at companies including UnitedHealth Group and Blue Cross Blue Shield of California. The group also receives about 10 percent of its funding from insurance companies, according to its website.” Click here to view the article.
5. ‘Patients Are the Real Experts': DO Wraps Up $1.2 Million PCORI Project
Laura Selby of The DO reports, “Dr. Swigris is the principal investigator for a three-year, $1.2 million PCORI-funded project on how using supplemental oxygen affects quality of life for patients with pulmonary fibrosis. The project kicked off in August 2013 and will stop collecting data on patients, who were tracked for one year each, later this month...For other DOs who'd like to pursue research funding through PCORI, Dr. Swigris's advice is simple: Talk to patients. ‘Patients are the real experts on their disease,’ he says. ‘If you can marry your clinical interests with their wishes and needs, that provides a great setup for a study.’” Click here to view the article.
