In This Week’s Issue:
1. PIPC Alert on Patient Access! see details below.
2. NHC Webinar: The Patient Voice in Value, click here to view the webcast.
3. Weighing Value and Patient Preference in Cancer Care: NCCN Evidence Blocks, click here to view the article.
4. CMS Seeks Input on Medicare's Value-Based Insurance Design Model, click here to view the article.
5. Rethinking ‘Patient Centricity’: Using Technologies To Distribute Clinical Trial Results Direct To Patient, click here to view the article.
6. GAO Issues Favorable Report on PCORI Financing, click here to view the report.
7. Video: PCORnet Best Kept Secret of a National Treasure, click here to view the video.
1. PIPC Alert on Patient Access! see details below.
2. NHC Webinar: The Patient Voice in Value, click here to view the webcast.
3. Weighing Value and Patient Preference in Cancer Care: NCCN Evidence Blocks, click here to view the article.
4. CMS Seeks Input on Medicare's Value-Based Insurance Design Model, click here to view the article.
5. Rethinking ‘Patient Centricity’: Using Technologies To Distribute Clinical Trial Results Direct To Patient, click here to view the article.
6. GAO Issues Favorable Report on PCORI Financing, click here to view the report.
7. Video: PCORnet Best Kept Secret of a National Treasure, click here to view the video.
1. PIPC Alert on Patient Access!
On March 8, 2016, the Center for Medicare and Medicaid Services (CMS) proposed a new Part B Drug Payment Model calling for centralized use of comparative effectiveness and cost-effectiveness reports as the basis for national Medicare policy. The Partnership to Improve Patient Care (PIPC) is strongly opposed to the approach outlined by CMS. First, despite our continued advocacy for patient engagement in the development of alternative payment models, this proposal appears to have been rushed forward with little or no input from the patient community. The phase involving CMS use of CER and cost-effectiveness analysis is set to begin early in 2017 and will eventually cover 75 percent of providers and their patients. Second, it directly contradicts PIPC's mission and long-standing efforts to support patient-centered approaches to comparative effectiveness research and payment and delivery reform. Third, by relying on value assessment tools intended to drive centralized coverage decisions, it creates substantial new barriers to patient access and undermines the movement toward patient-centered health care.
We urge patients, people with disabilities, caregivers and providers to voice their concern about the agency's proposal. PIPC is developing additional background materials on this critically important proposed rule and will be circulating them in the coming days. In the meantime, we encourage you to review recent commentary by PIPC Chairman Tony Coelho at The Huffington Post, Morning Consult, and Roll Call. These commentaries included statements from Mr. Coelho that are particularly salient in considering CMS' proposed rule:
“Nowhere in this ‘value’ discussion do we see an honest consideration of the real-world impact these proposals would have on the individual patient or the person with a disability for whom an innovation may have significant value. Yet nothing is more dangerous to the practice of patient-centered care than an academically pristine algorithm in the hands of a bureaucrat. I say it often and I'll say it again: no patient is ‘average.’ And proposals that set national policy based on judgments of average value pose a grave risk to patients and especially, people with disabilities.” The Huffington Post, February 4, 2016
“The approach that emerged from our [2015 Oncology Roundtable] forum - one that advances value for all patients while respecting differences in values among patients - is diametrically opposed to renewed calls for policy-making grounded in centralized value judgments and cost-effectiveness thresholds...There would in fact be significant costs, both for the healthcare system and for my quality of life, if I were treated as an ‘average’ epilepsy patient - more seizures, hospitalizations, and doctor visits, in addition to the stresses of my recovery.” Morning Consult, November 19, 2015
“So we again face a choice. Will we continue conduct CER to support patient needs and the science of personalized and “precision” medicine, or are we going back to the paternalistic days of patting patients on the head, telling them to take two pills and call back in the morning. I cannot imagine patients want to be sidelined in their own care decisions based on centralized value assessments from CER studies that are meaningless to them personally. We’ve come too far in building the research and innovation infrastructure that enables personalized decisions to throw it all away because we do not systematically believe patients should be driving their own care. As PIPC’s Chairman and a patient with a disability myself, I would urge policymakers to move forward – not backward – and to embrace the ideals of patient-centered, personalized medicine.” Roll Call, October 16, 2015
2. NHC Webinar: The Patient Voice in Value
Last week, the National Health Council (NHC) held a webinar entitled The Patient Voice in Value. The webinar highlighted the NHC’s Patient-Centered Value Model Rubric, which you can download here. The purpose of the Value Model Rubric is to provide a tool that the patient community, physicians, health systems, and payers can use to evaluate the patient centeredness of value models and to guide value model developers on the meaningful incorporation of patient engagement throughout their processes. If you were unable to participate in Monday’s webinar, NHC has posted a recording of the webinar and the presentation slides. The NHC invites use of this model by health care stakeholders and welcomes comments based on use experiences that can help us strengthen the Value Model Rubric. Additionally, an article about the rubric in BioCentury titled “Valuing Patients” can be found here (subscription required).
3. Weighing Value and Patient Preference in Cancer Care: NCCN Evidence Blocks
According to an article in The American Journal of Managed Care, “[Robert Carlson, MD] emphasized the fact that there is no ‘one size fits all’ approach to cancer care: while a younger patient might want the most effective treatment despite the side effects, an older patient might be more concerned with the impact of treatment on quality of life. Some patients might be more concerned with affordability. NCCN's Evidence Blocks have been devised to ease these discussions between physicians and patients, Carslon said. These are a graphic representation of 5 value measures, including efficacy, safety, quality and quantity of evidence, consistency of evidence, and affordability.” Click here to view the article.
4. CMS Seeks Input on Medicare's Value-Based Insurance Design Model
The National Law Review reports “Medicare Advantage plans had historically been unable to take advantage of VBID designs due to a federal prohibitions against varying benefit designs within a plan based on health status or other enrollee characteristics. To overcome this obstacle, CMS pointed to its authority under the Affordable Care Act to test innovative health care payment service delivery models. The model test will allow Medicare Advantage Organizations to offer VBID interventions to enrollees with diabetes, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), patients with past stroke, hypertension, coronary artery disease, and mood disorders.” Click here to view the article.
5. Rethinking ‘Patient Centricity’: Using Technologies To Distribute Clinical Trial Results Direct To Patient
According to an article in Clinical Leader, “the drug development community is increasingly turning to patient engagement or ‘patient centricity’ approaches to optimize clinical trials costs and improve research outcomes. The active participation of patients in clinical research can potentially lead to improvements in the credibility of results, higher rates of enrollment and retention, and ultimately, lower trial costs. Sponsors have been taking the initiative to get in touch with patients to better understand and reinvent the clinical trial process. And governments are also taking action. In 2010, the US government created the Patient Outcomes Research Institute (PCORI) with a $3 billion dollar budget to support research designed to help doctors and patients make informed health care decisions. A central goal of PCORI is ensuring that patients are involved in driving decisions such as determining research priorities, reviewing grants, and providing input on issues that relate to PCORI’s mission.” Click here to view the article.
6. GAO Issues Favorable Report on PCORI Financing
A new report from the Government Accountability Office (GAO) found no significant isssues in the financial statements of the Patient-Centered Outcomes Research Institute’s (PCORI). As the report explains, “Based on the procedures performed by GAO regarding the independent public accountant’s (IPA) financial audit of [PCORI’s] fiscal year 2015 financial statements, GAO did not identify any significant issues related to the financial statement audit that it believes require attention. The IPA provided an unmodified audit opinion on PCORI’s fiscal years 2015 and 2014 financial statements. Specifically, the IPA found that PCORI’s financial statements were presented fairly, in all material respects, in accordance with U.S. generally accepted accounting principles. Further, for fiscal year 2015, the IPA did not identify any deficiencies in internal control that it considered to be material weaknesses or any reportable noncompliance with the selected provisions of laws, regulations, contracts, and grant agreements it tested.” Click here to view the report.
7. Video: PCORnet Best Kept Secret of a National Treasure
In a video for PCORI, Robert McBurney, president and CEO of the Accelerated Cure Project, discusses why he believes PCORnet is ‘the nation's best kept secret.’” Click here to view the video.
On March 8, 2016, the Center for Medicare and Medicaid Services (CMS) proposed a new Part B Drug Payment Model calling for centralized use of comparative effectiveness and cost-effectiveness reports as the basis for national Medicare policy. The Partnership to Improve Patient Care (PIPC) is strongly opposed to the approach outlined by CMS. First, despite our continued advocacy for patient engagement in the development of alternative payment models, this proposal appears to have been rushed forward with little or no input from the patient community. The phase involving CMS use of CER and cost-effectiveness analysis is set to begin early in 2017 and will eventually cover 75 percent of providers and their patients. Second, it directly contradicts PIPC's mission and long-standing efforts to support patient-centered approaches to comparative effectiveness research and payment and delivery reform. Third, by relying on value assessment tools intended to drive centralized coverage decisions, it creates substantial new barriers to patient access and undermines the movement toward patient-centered health care.
We urge patients, people with disabilities, caregivers and providers to voice their concern about the agency's proposal. PIPC is developing additional background materials on this critically important proposed rule and will be circulating them in the coming days. In the meantime, we encourage you to review recent commentary by PIPC Chairman Tony Coelho at The Huffington Post, Morning Consult, and Roll Call. These commentaries included statements from Mr. Coelho that are particularly salient in considering CMS' proposed rule:
“Nowhere in this ‘value’ discussion do we see an honest consideration of the real-world impact these proposals would have on the individual patient or the person with a disability for whom an innovation may have significant value. Yet nothing is more dangerous to the practice of patient-centered care than an academically pristine algorithm in the hands of a bureaucrat. I say it often and I'll say it again: no patient is ‘average.’ And proposals that set national policy based on judgments of average value pose a grave risk to patients and especially, people with disabilities.” The Huffington Post, February 4, 2016
“The approach that emerged from our [2015 Oncology Roundtable] forum - one that advances value for all patients while respecting differences in values among patients - is diametrically opposed to renewed calls for policy-making grounded in centralized value judgments and cost-effectiveness thresholds...There would in fact be significant costs, both for the healthcare system and for my quality of life, if I were treated as an ‘average’ epilepsy patient - more seizures, hospitalizations, and doctor visits, in addition to the stresses of my recovery.” Morning Consult, November 19, 2015
“So we again face a choice. Will we continue conduct CER to support patient needs and the science of personalized and “precision” medicine, or are we going back to the paternalistic days of patting patients on the head, telling them to take two pills and call back in the morning. I cannot imagine patients want to be sidelined in their own care decisions based on centralized value assessments from CER studies that are meaningless to them personally. We’ve come too far in building the research and innovation infrastructure that enables personalized decisions to throw it all away because we do not systematically believe patients should be driving their own care. As PIPC’s Chairman and a patient with a disability myself, I would urge policymakers to move forward – not backward – and to embrace the ideals of patient-centered, personalized medicine.” Roll Call, October 16, 2015
2. NHC Webinar: The Patient Voice in Value
Last week, the National Health Council (NHC) held a webinar entitled The Patient Voice in Value. The webinar highlighted the NHC’s Patient-Centered Value Model Rubric, which you can download here. The purpose of the Value Model Rubric is to provide a tool that the patient community, physicians, health systems, and payers can use to evaluate the patient centeredness of value models and to guide value model developers on the meaningful incorporation of patient engagement throughout their processes. If you were unable to participate in Monday’s webinar, NHC has posted a recording of the webinar and the presentation slides. The NHC invites use of this model by health care stakeholders and welcomes comments based on use experiences that can help us strengthen the Value Model Rubric. Additionally, an article about the rubric in BioCentury titled “Valuing Patients” can be found here (subscription required).
3. Weighing Value and Patient Preference in Cancer Care: NCCN Evidence Blocks
According to an article in The American Journal of Managed Care, “[Robert Carlson, MD] emphasized the fact that there is no ‘one size fits all’ approach to cancer care: while a younger patient might want the most effective treatment despite the side effects, an older patient might be more concerned with the impact of treatment on quality of life. Some patients might be more concerned with affordability. NCCN's Evidence Blocks have been devised to ease these discussions between physicians and patients, Carslon said. These are a graphic representation of 5 value measures, including efficacy, safety, quality and quantity of evidence, consistency of evidence, and affordability.” Click here to view the article.
4. CMS Seeks Input on Medicare's Value-Based Insurance Design Model
The National Law Review reports “Medicare Advantage plans had historically been unable to take advantage of VBID designs due to a federal prohibitions against varying benefit designs within a plan based on health status or other enrollee characteristics. To overcome this obstacle, CMS pointed to its authority under the Affordable Care Act to test innovative health care payment service delivery models. The model test will allow Medicare Advantage Organizations to offer VBID interventions to enrollees with diabetes, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), patients with past stroke, hypertension, coronary artery disease, and mood disorders.” Click here to view the article.
5. Rethinking ‘Patient Centricity’: Using Technologies To Distribute Clinical Trial Results Direct To Patient
According to an article in Clinical Leader, “the drug development community is increasingly turning to patient engagement or ‘patient centricity’ approaches to optimize clinical trials costs and improve research outcomes. The active participation of patients in clinical research can potentially lead to improvements in the credibility of results, higher rates of enrollment and retention, and ultimately, lower trial costs. Sponsors have been taking the initiative to get in touch with patients to better understand and reinvent the clinical trial process. And governments are also taking action. In 2010, the US government created the Patient Outcomes Research Institute (PCORI) with a $3 billion dollar budget to support research designed to help doctors and patients make informed health care decisions. A central goal of PCORI is ensuring that patients are involved in driving decisions such as determining research priorities, reviewing grants, and providing input on issues that relate to PCORI’s mission.” Click here to view the article.
6. GAO Issues Favorable Report on PCORI Financing
A new report from the Government Accountability Office (GAO) found no significant isssues in the financial statements of the Patient-Centered Outcomes Research Institute’s (PCORI). As the report explains, “Based on the procedures performed by GAO regarding the independent public accountant’s (IPA) financial audit of [PCORI’s] fiscal year 2015 financial statements, GAO did not identify any significant issues related to the financial statement audit that it believes require attention. The IPA provided an unmodified audit opinion on PCORI’s fiscal years 2015 and 2014 financial statements. Specifically, the IPA found that PCORI’s financial statements were presented fairly, in all material respects, in accordance with U.S. generally accepted accounting principles. Further, for fiscal year 2015, the IPA did not identify any deficiencies in internal control that it considered to be material weaknesses or any reportable noncompliance with the selected provisions of laws, regulations, contracts, and grant agreements it tested.” Click here to view the report.
7. Video: PCORnet Best Kept Secret of a National Treasure
In a video for PCORI, Robert McBurney, president and CEO of the Accelerated Cure Project, discusses why he believes PCORnet is ‘the nation's best kept secret.’” Click here to view the video.
