December 13, 2019
Acting Director, Center for Medicare & Medicaid Innovation
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Submitted electronically to OCF@cms.hhs.gov
RE: Informal Request for Information on the Oncology Care First Model
Dear Acting Director Bassano:
The National Pharmaceutical Council (NPC) appreciates the opportunity to submit comments regarding the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMS Innovation Center) informal request for information (RFI) on the Oncology Care First (OCF) Model. NPC supports the agency’s continued efforts to improve health outcomes and quality of care for Medicare beneficiaries with cancer.
NPC is a health policy research organization dedicated to the advancement of good evidence and science and to fostering an environment in the United States that supports medical innovation. NPC is supported by the major U.S. research-based biopharmaceutical companies. We focus on research development, information dissemination, education and communication of the critical issues of evidence, innovation and the value of medicines for patients. Our research helps inform important health care policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.
As an organization that has conducted and partnered on extensive research on quality measures, our comments are based on previous, evidence-based work. Our comments focus on the following:
- Electronic patient-reported outcomes (ePRO) measures (ePROMs) and implementation support
- Inclusion of additional quality measures
- Patient involvement in all phases of program development and implementation
- Criteria for identifying nationally recognized clinical practice guidelines
- Cell and gene therapy exclusion from episode payment
NPC supports the inclusion of ePROMs in the OCF Model. The CMS Innovation Center should consider adopting a stepwise approach to ePROM implementation and offer resources for OCF Model practices to incentivize participation.
Patients are the most important source of information regarding experience of care and quality of life outcomes, and we applaud the CMS Innovation Center’s inclusion of ePROMs in the OCF Model. Using patient-reported outcomes measures (PROMs) in oncology can improve symptom management, health-related quality of life and survival.[1,2,3] ePROM use aligns with CMS’ quality priority to “Strengthen Person and Family Engagement as Partners in Their Care” in the Meaningful Measures Framework. Our white paper, “Improving Patient-Reported Measures in Oncology” discusses in depth the benefits and barriers to implementing PROMs and PRO-based performance measures (PRO-PMs) and informs the recommendations presented below. Based on our research, we suggest the following enhancements to the ePROM practice redesign activity outlined in the RFI:
Balance Standardization and Flexibility to Support Value-based Payment (VBP), Quality Improvement and Clinical Care
We suggest that future ePROMs requirements balance standardization (e.g., standardized EHRs, standardized outcomes) and flexibility to support implementation and use by OCF Model practices. NPC recommends the use of ePROMs that include standard, or “core” items, that can be used in the development of valid and reliable PRO-PMs (e.g., specific questions validated to measure key concepts such as symptoms and symptom burden). Practices should also be allowed to adapt these tools with additional data elements to help them assess and meet the unique needs of their patients. As discussed in the OCF Model listening session and noted by stakeholders participating in our research, many practices have already implemented ePROMs in which they invested significant resources in development, sometimes including customization, and implementation. Our research also shows that PROMs can be leveraged for the use cases of clinical care, quality improvement and accountability. The OCF Model should allow and support practices to build in required questions within existing tools, while retaining questions that meet all three use cases.
In an NPC survey of 18 stakeholders in oncology care (providers and patients, regulation/policy, quality measurement, employer purchasing, academic research, health insurance and patient advocacy), the PROMs indicated as most useful or promising for inclusion in accountability programs were: Patient-Reported Outcomes Measurement Information System (PROMIS), Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™), MD Anderson Symptom Inventory (MDASI), European Organisation for Research and Treatment of Cancer’s (EORTC) quality of life questionnaires, Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care and Functional Assessment of Cancer Therapy – General seven-item version (FACT-G7).
While the current Oncology Care Model (OCM) Experience of Care Survey drew extensively from the CAHPS Cancer Care , the CMS Innovation Center could consider these other tools as a starting point when determining which ePROMs or questions might be required in the OCF Model, building on them as needed to capture some of the concepts described below, such as symptomatic adverse events.
The CMS Innovation Center could also consider collaborating with current Food and Drug Administration (FDA) initiatives to use standardized tools to collect patient-reported data in cancer trials.[6,7] Alignment with FDA initiatives would promote standardization and efficiency in data collection efforts.
Provide Implementation Resources including Higher Year 1 Monthly Population Payment (MPP)
To provide financial resources for implementation of ePROMs, the CMS Innovation Center could consider offering a higher MPP in the first year of model participation to account for the cost and time required by practices to implement new data collection processes. Extra financial support for implementation at the beginning of the program may help incentivize provider participation in the OCF Model and encourage the use of PROMs. For practices that are not currently using ePROMs, CMS could also provide a validated and fit-for-purpose publicly available ePROM to support implementation and use in the OCF Model.
Plan Ahead for PRO-PM Development and Implementation
To measure performance, the CMS Innovation Center could plan to implement PRO-PMs after initial ePROM implementation and add them to the program’s list of quality measures. Symptoms and symptom burden were among the top PRO-PM concepts recommended for inclusion in VBP programs in a survey conducted for our patient-reported measure (PRM) white paper (see Figure 1).
Figure 1. Survey Results on Measure Domain Priorities for VBP
Source: Improving Patient-Reported Measures in Oncology. NPC and Discern Health.
Likewise, a roundtable of expert stakeholders we convened for the project suggested that measure developers should focus efforts on the following specific concepts for PRO-PM inclusion in accountability programs:
- Symptoms interfered with daily activities
- Symptoms and functional status were collected and conveyed to providers
- Provider assessed patients for emotional or social status concerns and offered referral to treatment
- Patient goals and values were considered across cancer treatment processes
As discussed in our white paper, existing PROMs and PRO-PMs may be leveraged for this process. For example, the Oncology Nursing Society (ONS) Patient Reported Health-Related Quality of Life (HRQOL) during Treatment for Advanced Cancer measure leverages the FACT-G or PROMIS Global Health short form (Version 1.2) to capture change in symptoms, function and well-being.[8,9,10] These first three concepts also generally align with the FDA focus on “symptomatic adverse events, physical function and disease-related symptoms [as] key contributors to the effect of a therapy on [health-related quality of life]” and could thus support clinical trials in addition to patient care and accountability. The fourth concept, consideration of patient goals and values, is especially pertinent to the OCF Model, and NPC recommends that the CMS Innovation Center collect information via ePROMs that can assess care concordance with patient goals and use these to support development and implementation of a PRO-PM.
Finally, literature on the process of shared decision-making (SDM) has found it increases patient satisfaction, reduces decisional conflict and improves care outcomes. As reported in our 2017 article, “Improving Oncology Quality Measurement in Accountable Care,” a roundtable of oncology stakeholders prioritized patient-reported measures (PRMs) of SDM as a key opportunity for improving measurement for oncology VBP programs. However, SDM may not always be utilized in the cancer space where patients and families may rely on expert advice or may not fully understand the options offered and the choices they can make. The CMS Innovation Center has been studying SDM using data collected during the OCM demonstration from the Experience of Care Survey. We recommend that the CMS Innovation Center share expanded findings of this evaluation and explore the opportunity to include a PRO-PM related to SDM in the OCF Model.
NPC recommends that additional measures be included as part of the quality strategy in the OCF Model.
While we support the continued use of cross-cutting measures in the OCF Model, we do not agree that the OCM measure set is sufficient to represent the “best way to assess high-quality care in oncology today,” as noted in the RFI. The CMS Innovation Center has an opportunity to use the OCF Model to expand beyond the current state of cancer quality measurement and accountability. In addition to the PRO-PM opportunities discussed above, potential measurement opportunities include:
To fill measure gaps, the OCF Model is an opportunity to develop and test new measures related to health-related quality of life, cancer recurrence, disease-free/ progression-free survival rates and other important outcomes in oncology care as described in “Improving Oncology Quality Measurement in Accountable Care.” Roundtable participants of that project discussed the need for safety measures (including patient-reported measures) to capture “never events” for inappropriately calibrated treatments, such as chemotherapy. The inclusion of additional outcome measures can encourage the use of targeted treatments or therapies that may otherwise be overlooked due to cost considerations.
To incentivize data collection, participants could receive financial support to collect and report data as part of the measure testing process, without being held accountable for performance during the testing. Provided the effort is well-coordinated, this has the potential to result in new validated measures that could be used in other programs and settings.
Appropriate Utilization and Care Coordination
If services such as imaging and laboratory services are included in the OCF Model MPP, the CMS Innovation Center should explore measures of appropriate utilization. Such measures would promote and facilitate patient access to recommended services and ensure that quality controls are in place to counterbalance cost-cutting attempts by practices that seek to reduce expenses. Measuring appropriate treatment in oncology is a challenge due to differences by cancer type and the rapid development of new therapies, but the OCF Model should include measures of appropriate treatment for the same reasons. Cross-cutting measures of SDM and guideline adherence (including guidelines related to the use of imaging, labs, and appropriate use of biomarker tests to drive treatment decisions) may help maintain patient access to needed therapies.
Bolstering cross-cutting measures around care coordination between different disciplines may also help to ensure patients are supported throughout treatment and improve other outcomes. Care coordination could potentially be assessed via patient-reported, provider-reported or other measures.
Patient Goal Concordance
The proposed OCF Model emphasizes the importance of documenting a care plan as a care redesign activity, and the National Academy of Medicine’s 13 components of a care management plan (also required) include documenting patient care goals. The CMS Innovation Center should go beyond documentation to promote care concordant with patients’ goals and wishes. The ONS Quality Improvement Registry includes a “Goal Setting and Attainment for Cancer Survivors” measure approved for the Quality Payment Program that could be a good interim measure, but this is a process measure also focused on documentation and does not ultimately capture concordance from the patient’s perspective. Thus, the ONS measure is not sufficient to capture goal concordant care in the long term.
As discussed above, the CMS Innovation Center should take steps to promote future inclusion of a cross-cutting PRO-PM of goal attainment and care concordance by ensuring that implemented ePROs include questions to assess these concepts. The stakeholder participants in our PRM roundtable identified goal attainment and care concordance as an opportunity for filling gaps in PRMs for oncology, potentially drawing on existing cross-cutting tools and measures.
Clinical Trial Enrollment
The existing OCM measure set does not include a measure of clinical trial enrollment, another area identified as a gap in our “Improving Oncology Quality Measurement in Accountable Care” work. The CMS Innovation Center has an opportunity to promote patient access to new technologies and potentially life-saving treatment by adding a measure of clinical trial enrollment for eligible patients to the OCF Model.
NPC recommends that patients, their caregivers, and other stakeholder groups be involved throughout all phases of program development and implementation.
Our research on quality measurement in oncology VBP programs has surfaced stakeholder concerns that “value” is often defined from the payer perspective and may not be meaningful to patients and family caregivers. This concern extends from the design of payment programs that incentivize providers to cut costs to the meaningfulness of the quality measures used to ensure that cost-cutting efforts do not undermine quality. One of the National Quality Forum (NQF) criteria for measure evaluation, “Importance to Measure and Report,” describes meaningfulness as follows: “for measures derived from patient reports, evidence should demonstrate that the target population values the measured outcome, process, or structure and finds it meaningful.” If the measures used in VBP programs are not meaningful to patients, the goal of paying for “value” has not been met.
To represent the patient perspective on oncology care, ensure that the OCF Model incentivizes value for patients, and include measures that are meaningful, the CMS Innovation Center should involve patients and families in all phases of program and measure development, implementation and evaluation. Our discussions with patients and other stakeholders revealed that different patients have different perspectives, needs and priorities, so a diversity of patients should be included to represent the diverse conditions and treatments of cancer patients.
Including patients in measure and program development is consistent with the principles of national organizations and the strategic goals of CMS:
- NQF identifies patients as the most valuable and authoritative source of information in assessing the quality of health care.
- CMS has a strategic goal to “empower patients and doctors to make decisions about their health care” and a goal of CMS’s Meaningful Measures framework is to prioritize measures that are meaningful to patients. Including patients and families in OCF program design and measure selection/development can help advance both of these goals at the program level.
- The Blueprint for the CMS Measures Management System also states, “Measure developers should prepare a plan for how patient input will be solicited, gathered and meaningfully incorporated into measure development and maintenance processes…”
The CMS Innovation Center should also involve technology vendors and biopharmaceutical manufacturers in program development and implementation to ensure providers transition seamlessly to the new model without patients losing access to needed therapies.
- Vendors of health information technology systems can help with implementation of data collection for measures and decision support systems for guideline adherence. Involving these stakeholders early in the process will promote collaboration to minimize administrative and technological burden of new program requirements.
- The CMS Innovation Center should leverage the scientific expertise of biopharmaceutical manufacturers to ensure that emerging evidence of life-saving therapies is considered in model development. This is especially important because this model features a shared-risk approach, and understanding the changing therapeutic landscape can help the CMS Innovation Center align incentives to encourage appropriate use of breakthrough treatments and avoid unintentionally restricting access due to cost constraints.
NPC recommends that criteria be established for identifying nationally recognized clinical practice guidelines and that clinical pathways not be used as a proxy for such guidelines.
We agree that beneficiaries in the OCF Model should be treated with therapies consistent with nationally recognized clinical guidelines as specified in the Enhanced Services section of the OCF Model. We recommend that the CMS Innovation Center clearly define criteria for guidelines to be recognized in the program and measure adherence to guideline recommendations. The criteria should include transparency during development, meeting codified standards, and prioritizing high-quality evidence.
We do not recommend that clinical pathways be used as a proxy for nationally recognized clinical guidelines. Clinical pathways are evidence-based protocols that help providers choose treatment options (such as dosing, time frames, and therapy sequencing) based on individual patient data.[20,21] Although they often reference the same literature sources as guidelines, pathways often suggest a single therapy from the acceptable options for certain disease characteristics, which guidelines may not.
In June 2019, we published a review on the use of (clinical) care pathways in the U.S. and shared results from a literature review; survey research; and interviews with payers, providers, pathway vendors and opinion leaders. This research found high variation in the process to develop pathways and lack of transparency and accountability around developers’ potential conflicts of interest. We also found that cost considerations were typically a core motivation for pathway development. Furthermore, our study identified a lack of patient awareness about pathways; most on-pathway patients were not provided education about pathways or disclosures about provider financial incentives related to pathways.
Given these concerns, we do not believe that clinical pathways are reliably sufficient to ensure continued access to patient-centered care and appropriate treatments. Because pathways may be primarily used to reduce costs, more evidence of their efficacy for ensuring good patient outcomes is needed before they are incorporated into a VBP program like the OCF Model.
NPC recommends that cell and gene therapy be excluded from episode target price and reconciliation.
NPC is involved in ongoing discussions with stakeholders about innovative financing solutions for curative therapies. We recommend that approved cell and gene therapies (i.e., CAR-T) be excluded from setting the episode target price and reconciliation to determine performance-based payment. In the OCM, two approved cell and gene therapies are excluded from episode cost reconciliation , and we suggest that this be used as a precedent for more explicit exclusions in the OCF Model, which currently does not offer clarity on the payment mechanisms for the broader categories of therapies. These treatments have a high one-time cost but can lead to better health-related quality of life and survival outcomes for patients. Potential for misaligned incentives make cell and gene therapies inappropriate for inclusion for several key reasons:
- Practices that use cell and gene therapies would have trouble meeting financial targets. The up-front costs of these medications may exceed any novel therapies adjustment, increasing provider difficulty in meeting the episode target price. This could influence treatment decisions and limit patient access to breakthrough therapies.
- The OCF Model does not offer quality or financial benefits for using these treatments. Improved outcomes may occur outside of the six-month episode covered by the OCF Model, and these outcomes are not assessed in the current measures. Likewise, reduced downstream costs (e.g., from avoided chemotherapy or hospitalization) would not be captured in the episode.
NPC suggests that the CMS Innovation Center provide an additional opportunity for stakeholders to comment on the OCF Model.
NPC appreciates the opportunity to provide comments on the proposals above, and we would like an opportunity to review additional model details and provide feedback on changes and additions to the proposed OCF Model prior to implementation. We look forward to continuing to collaborate with CMS to improve the health of Medicare beneficiaries. We hope to continue this important discussion with CMS and other stakeholders and would be happy to meet to expand upon our comments and share our research.
Robert W. Dubois, MD, PhD
Chief Science Officer
Kimberly Westrich, MA
Vice President, Health Services Research
 Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318(2):197-198. doi: 10.1001/jama.2017.7156.
 Zhang B, Lloyd W, Jahanzeb M, Hassett MJ. Use of patient-reported outcome measures in Quality Oncology Practice Initiative–registered practices: Results of a national survey. J Oncol Pract. 2018;14(10): e602-e611. doi: 10.1200/JOP.18.00088.
 Basch E, Deal AM, Kris MG, et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34(6):557-565. doi: 10.1200/JCO.2015.63.0830.
 Valuck T, Schmidt T, Perkins B, Patel P, Westrich K, Basch E, McClellan M. Improving patient-reported measures in oncology. National Pharmaceutical Council website. https://www.npcnow.org/publication/improving-patient-reported-measures-oncology. Published February 21, 2019. Accessed December 2, 2019.
 Centers for Medicare and Medicaid Services. OCM performance-based payment methodology. Version 5.1. Centers for Medicare and Medicaid Services website. https://innovation.cms.gov/Files/x/ocm-pp3beyond-pymmeth.pdf. Published December 17, 2018. Accessed December 2, 2019.
 U.S. Food and Drug Administration. DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). U.S. Food and Drug Administration website. https://www.fda.gov/drugs/development-approval-process-drugs/ddt-coa-000009-non-small-cell-lung-cancer-symptom-assessment-questionnaire-nsclc-saq. Updated October 11, 2019. Accessed December 10, 2019.
 U.S. Food and Drug Administration. Real-World Evidence. U.S. Food and Drug Administration website. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Updated May 9, 2019. Accessed December 10, 2019.
 Oncology Nursing Society. 2019 Oncology QCDR measure specifications. Medconcert website. https://www.medconcert.com/content/medconcert/ONSQIR/2019_Oncology_QCDR_Measure_Specifications_02062019.pdf. Accessed December 2, 2019.
 PROMIS short form - global - version 1.2. LOINC website. https://loinc.org/85524-7/. Accessed December 2, 2019.
 Cella D. Questionnaires. FACIT website. https://www.facit.org/FACITOrg/Questionnaires. Accessed December 2, 2019.
 Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH et al. Focusing on core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptoms. Clinical Cancer Research 2016; 22(7): 1553-1558. doi: 10.1158/1078-0432.CCR-15-2035
 Hess EP, Hollander JE, Schaffer JT, et al. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016;355:i6165. doi: 10.1136/bmj.i6165.
 Valuck T, Blaisdell D, Dugan DP, et al. Improving oncology quality measurement in accountable care: Filling gaps with cross-cutting measures. J Manag Care Spec Pharm. 2017;23(2):174-181. doi: 10.18553/jmcp.2017.23.2.174.
 Valuck T, Blaisdell D, Schmidt T. Catch me if you can: Aligning quality measurement with oncology innovation. Journal of Clinical Pathways. https://www.journalofclinicalpathways.com/commentary/catch-me-if-you-can-aligning-quality-measurement-oncology-innovation. Published November 22, 2019. Accessed December 2, 2019.
 Centers for Medicare & Medicaid Services Innovation Center. Oncology Care Model overview. Centers for Medicare and Medicaid Services website. https://innovation.cms.gov/Files/slides/ocm-overview-slides.pdf. Published July 2019. Accessed December 2, 2019.
 National Quality Forum. Measure evaluation criteria and guidance for evaluating measures for endorsement. September 2018. National Quality Forum website. https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=88439. Accessed December 2, 2019.
 National Quality Forum. Patient-reported outcomes. National Quality Forum website. https://www.qualityforum.org/Patient-Reported_Outcomes.aspx. Accessed December 2, 2019.
 Centers for Medicare and Medicaid Services. Meaningful Measures hub. CMS.gov. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page. Updated September 10, 2019. Accessed December 2, 2019.
 Centers for Medicare and Medicaid Services. Blueprint for the CMS Measures Management System. Version 15.0. CMS.gov. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf. Published September 2019. Accessed December 2, 2019.
 American Society of Clinical Oncology. Checklist: evaluating oncology clinical pathways programs. ASCO website. https://www.asco.org/sites/new-www.asco.org/files/content-files/2018-ASCO-Clinical-Pathways-Checklist.pdf. Accessed December 12, 2019.
 Chiang AC, Ellis P, Zon R. Perspectives on the use of clinical pathways in oncology care. Am Soc Clin Oncol Educ Book. 2017; 37:155-159.
 Chawla A, Westrich K, Dai A, Mantels S, Dubois RW. US care pathways: continued focus on oncology and outstanding challenges. Am J Manag Care. 2019;25(6):280-287.
 Paying for cures: Ensuring patient access and system sustainability. National Pharmaceutical Council website. https://www.npcnow.org/blog/paying-cures-ensuring-patient-access-and-system-sustainability. Published February 19, 2019. Accessed December 2, 2019.
 OCM Drug List. CMS website. https://innovation.cms.gov/Files/x/ocm-druglist.xlsx