September 14, 2022

The Honorable Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
United States Department of Health and Human Services
200 Independence Avenue SW
Washington, D.C.  20201

Elizabeth Fowler, PhD, JD, Deputy Administrator and Director
Center for Medicare and Medicaid Innovation
Centers for Medicare & Medicaid Services
United States Department of Health and Human Services
7500 Security Boulevard
Baltimore, M.D. 21244

Re: Concerns with the Enhancing Oncology Model

Dear Administrator Brooks-LaSure and Deputy Administrator Fowler:

On behalf of the Community Oncology Alliance (“COA”), we are submitting our concerns regarding the Enhancing Oncology Model (“EOM”) to the leadership at the Centers for Medicare & Medicaid Services (“CMS”) and Center for Medicare and Medicaid Innovation (“CMMI”).  Please understand that the concerns voiced in this letter are reflective of our COA Oncology Payment Reform Committee, whose members were participants in the Oncology Care Model (“OCM”) and many other commercial payment reform initiatives.

As you know, COA is an organization dedicated to advocating for the complex care and access needs of patients with cancer and the community oncology practices that serve them.  COA is the only nonprofit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer.  Since its grassroots founding close to 20 years ago, COA’s mission has been to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work, regardless of their racial, ethnic, demographic, or socioeconomic status.

We appreciate that CMMI continues to focus on improving the quality of cancer care for Medicare beneficiaries while reducing the total cost of care.  The experience CMMI gained with the OCM, including the technical variables that can impact cancer costs, is impressive.  However, COA has significant concerns about the EOM that we would like to share as we strive to align reform efforts and goals of cancer care teams with payers of all types.

COA is extremely concerned that without changes, the EOM could fail to recruit a meaningful number of oncology practices – especially independent community oncology practices – causing it to fail as a demonstration project and as a model that can realistically transform the U.S. cancer care and payment system for the better.  A survey of 155 practices conducted by COA in late July 2022 found less than half (42.6 percent) that participated in the OCM planned to participate in the EOM.  Of all practices, OCM and non-OCM, just over a third (32.2 percent) said they planned to participate.  Since that survey was conducted, little has been revealed about the EOM that would lead COA to believe that many practices will change their mind about joining without some of the changes and suggestions outlined in this letter taking effect.

We want to make it very clear that not only is COA committed to oncology payment reform, but we also want the EOM to be successful.  With the OCM, COA had over 80 percent of OCM participants in a collaborative effort that shared information on best practices.  We have already started a similar collaboration for practices considering participation in the EOM.

With that said, COA has some pressing and key concerns with the EOM impact on patient care management, Social Determinants of Health (“SDOH”) and Electronic Patient Reported Outcomes (“ePROs”), payment methodology, and qualification of the EOM for the Advanced Alternative Payment Model (“AAPM”) within Medicare’s Quality Payment Program (“QPP”).

Care Management

A balance must be struck between managing patients with cancer that are at the highest risk vs. providing services to all patients with cancer.  Limiting the model to only seven cancer types can create separate care systems and processes between patients with different cancers.  Our message remains: COA is committed to comprehensive and efficient improvements in quality and value for all patients with cancer with a goal of assuring consistent, high-quality, and equitable cancer care for all.  To limit the EOM to only seven cancers creates an inequity in care for patients with other cancers.  Yet, the EOM emphasizes health equity.

Although the care improvements are well intended in the EOM, they are far too specific and prescriptive.  COA’s Oncology Medical Home (“OMH”) model and ASCO’s Patient-Centered Cancer Care Certification (“APC4”) program have similar care expectations but are sensitive to team size, dynamics, current operations, community cultures, etc., and encourage the proof of meeting the standards, but in a manner that is best for the team as directed by the physicians.  Some examples include that OMH/APC4 cancer care teams must prove they are using a patient satisfaction system, measuring the findings for the team and their individual providers.  Similarly, teams are asked to show how they are addressing health inequities in their community, as well as identifying and addressing the patient’s needs.  The needs are different between communities.  The EOM is far too prescriptive regarding the tools and processes that are required for care transformation, and the CMMI mandated requirements are insensitive to community and care team cultures.  CMMI, regardless of input that may be provided to it by medical practitioners, should not be dictating to oncologists and allied health professionals how they practice medicine.  CMMI should simply provide the framework for practice within the EOM.

The EOM Request for Application (“RFA”) specifies that billing for Chronic Care Management services is prohibited.  The implication is that the $70 Monthly Enhanced Oncology Services (“MEOS”) payment will cover those services and more.  COA has two concerns with that position:

• The $70 MEOS payment will not cover the expenses that will be incurred to participate in this model. As evidenced by the OCM, OCM MEOS funds of $160 assisted in covering process changes for care transformation, outside consulting to interpret CMMI data, increasing care team staff, etc.  Expenses will be increased with EOM requirements, including mandating a tool(s) to address Health-Related Social Needs (“HRSN”) and ePRO data, as well as the eventual interface to a practice’s electronic medical record (“EMR”) system.
• The $70 EOM MEOS payment covering chronic care management services is inadequate and furthermore requires EOM participants to have two care processes: one for non-EOM patients and the other for EOM patients. Excluding recognized CPT codes for chronic care management and their requirements slights EOM patients from this important service.

Requiring EOM participants to provide assistance for HRSN without additional resources, with the possible validation of this effort in the EOM, is a burden to those leading the effort to reform cancer care.  This is even worse and unfair when comparing the financial support given to EOM practices to do this work with other government programs, such as hospitals participating in the 340B Drug Pricing Program (“340B”).  Very few, if any, 340B hospitals direct the program proceeds to patient-specific health-related social needs, nor are they required to validate how these funds are directed to that population.  Instead, the 340B program has evolved into a  get-rich-quick scheme for hospitals with at least a 50 percent profit on every 340B drug that is dispensed.  Multiple studies have demonstrated the uncontrolled abuse of the 340B program.  The need to address patient HRSNs are the same, regardless of their care setting or program under which they fall.  However, CMMI is essentially saying with the EOM that cancer care delivered in the community setting, which is proving to be of the greatest value with equal or even higher quality, is not worth supporting.

Social Determinants of Health and ePROs

COA applauds CMMI for including the SDOH measurement in the EOM.  There are many active initiatives within the cancer care community to understand and implement procedures to address health inequities.  They include identifying needs, then securing the appropriate resources to assist with those conditions that are adversely impacting the patient.  The burden of documentation will be great for practices that have historically not done this in the past.  The biggest challenge, however, remains the limited resources available in most communities.  Community practices, in particular, cannot be tasked with changing society, especially when needed resources are not available for identified needs.

A trusting relationship between cancer care teams and patients is critical to optimizing patient care.  Several COA practices have expressed concerns on how sharing SDOH data “with the government” can adversely affect patient trust, thus possibly resulting in patients actually abandoning care.  We want to underscore that trust is vitally important throughout the entire care journey.

COA is interested in the work done thus far on ePROs that shows a survival advantage.  Most of this work has been done in academic medical centers, which are vastly different than independent community oncology practices.  Community practices have known for some time that actively managing patient symptoms improves outcomes.  We are concerned about the inclusion of ePROs in the EOM with the lack of data regarding benefits in the community setting.  We also cannot underestimate the burden placed on practices and patients for implementing ePROs.  Managing ePROs will require significant staff time, plus the cost of partnering with a vendor and the cost of EMR interoperability.  There are several EMR systems serving community cancer centers, and this type of expense is typically placed directly on the practice.

The Patient-Reported Outcomes Measurement Information System (“PROMIS”), an entity of the United States Department of Health and Human Services, has over 300 measures of physical, mental, and social health for use with the general population and with individuals living with chronic conditions.  PROMIS recommends automated assessment triggers for gathering patient feedback.   For cancer care, that trigger may be the treatment itself.  Assessing outcomes at every office visit, as CMMI is proposing, will be redundant and burdensome for the patient and care teams and will likely create an overload of information that is difficult to manage.  This would be particularly true based on the measures that are chosen.

While COA agrees that collecting and using PROMs for clinical care is important, the frequency of PROMs collection that CMMI is proposing is simply unnecessary.  We suggest a measurement strategy that enables practices to collect and use PROMs for quality improvement by assessing PROMs at baseline prior to the start of treatment and as patients enter survivorship, which also builds capacity towards future outcomes measurement.  To this end, COA has developed and will soon launch a technical solution that will enable providers to collect and use PROMs in real time.  This solution will allow providers to view results and filter by provider, treatment regimen, and cancer type, among other things.  Moreover, the solution is available free to practices nationwide.

COA has developed this solution to align with the Patient-Reported Outcome Measures for Cancer Care (“PROMOnc”) PRO-PM measure specifications developed by the Purchaser Business Group on Health (“PBGH”).  The PROMOnc conceptual development was grounded in the evidence-based premise that medical oncologists who provide the highest quality care (including medical and non-medical support services) to patients receiving curative-intent cytotoxic therapy can reduce longer-term symptom burden and thus improve patient transition into the cancer survivorship period.^1,2,3,4 These PRO-PMs target symptom outcomes of cancer diagnosis and treatment that persist and impact patient re-entry into cancer survivorship. These measures use PROMIS scales to assess pain interference, fatigue, and health-related quality of life (physical and mental health).  PBGH has submitted these measures to the CMS Measures Under Considering (MUC) list and the National Quality Forum (“NQF”) for endorsement.  We encourage CMMI to leverage the work already underway with the PBGH PROMOnc PRO-PM measures and COA’s technical solution to collect and use PROMs at clinically meaningful timepoints that enable practices to improve quality and prepare for outcomes measurement.[1]  CMMI should not be reinventing the wheel in this area and must not mandate processes that are not supported by research and high-quality medical practice.

Payment Methodology

Transparent methodology is vital to promote accountability in all value-based initiatives.  As a key component to successful initiatives, the entities must agree in advance on the criteria and methodology utilized, as well as evaluating both throughout the program.  This promotes accountability for both parties – providers and payers.  EOM participants need a clear and thorough understanding of their expectations in care and financial goals prior to each recognition period so that they can make appropriate care decisions.  Presenting this specific information to each EOM participant prior to the beginning of each performance period will promote transparency and collaborative effort within the entire cancer care team.  This was not done with the OCM, and CMMI must learn from deficiencies in this area. 

Community oncology practices currently have an inordinately high level of risk with proposed CMS Medicare payment cuts, such as increased staffing, material costs due to inflation, and other declining reimbursement, including the sequester.  Risk must be balanced for these practices.  Over the last two decades, COA has tracked a significant movement of physician-run community-based cancer care to hospital systems, which only increases the cost of care two to three-fold, as well as closures of practices, which can limit patient access to treatment.  The unproven risk models of the EOM could prove to be detrimental to many community practices.  Each time the door is closed to an independent community oncology practice, there is an additional increase in the cost of cancer care to Medicare, payers,  beneficiaries, and employers.

Cancer care teams are already mindful and are held accountable for quality and costs.  The methodology in the EOM is totally focused on lowering costs, with adjusters for quality or data reporting.  The Merit-based Incentive Payment System (“MIPS”), the alternative, weighs cost at 30 percent, quality at 30 percent, improvement activities at 15 percent, and promotion of interoperability at 25 percent.  That seems to represent a more balanced focus on quality, efficiency, and cost.  CMMI states that its goals for its models are to “Improve patient care, lower costs, better align payment systems to promote patient-centered practices.”  However, the EOM payment methodology targets the total cost of care for a select type of patient and holds EOM participants accountable if they do not save Medicare money.  The MIPS QPP addresses all components of the care process.

Existing and meaningful reform models, or value-based arrangements, are collaborative initiatives with a win-win scenario and shared risk.  In contrast, 100 percent of the risk remains with the participant in the EOM.  Cancer care teams may lose in that model, with financial penalties paid to Medicare.  Yet, CMS/CMMI has no risk in this model.  Even if teams achieve a performance-based payment, the MEOS will be recouped due to the 98 percent threshold.  Generally, community-based cancer care teams are interested and are focused on reform.  However, immediately mandating two-sided risk, including for those that did not participate in the EOM, with a complex and opaque model, causes great concern and may well limit participation.

COA and the cancer care teams we represent are seeking meaningful reform for all stakeholders and all sites of care.  Progress in that direction requires standardization in all areas – including meaningful payment methodology.  We counted 55 different adjustments that would be applied to the target prices for each EOM participant.  To date, we have not identified any commercial insurance payer or any cancer care team that can emulate the EOM methodology without retaining the professional services of an experienced data company and/or consultant.  With all that is involved in submitting and adjudicating cancer care claims, a model is needed that can be emulated and audited.

Qualification of the EOM for AAPM and QPP

Cancer care teams must balance many variables when considering future operations and long-term plans.  There were incentives under the OCM program that encouraged participation in a two-sided risk arrangement – a bonus as a validated AAPM.  The current CMS methodology removes the five percent AAPM bonus, and the remaining incentive fee schedule adjustments are likely not enough of an incentive to encourage practices to accept risk.

The QPP has qualifications for Alternative Payment Model (“APM”) and AAPM classifications.  Risk arrangements one and two will qualify as a MIPS APM.  In risk arrangement two, participants will qualify as an AAPM and would be exempt from other MIPS reporting.  In published data from CMMI, OCM practices had just 50 percent of payments under the OCM and 25 percent of patients treated in the model.  That trend would not qualify EOM participants as an AAPM and a MIPS exemption.  Those ratios would be even lower with only seven cancers in the EOM.

With fewer qualifying patients with cancer in the EOM, it will be nearly impossible for any practice to achieve QPP AAPM status.  Per our community, many practices in the OCM accepted risk only because this allowed them to achieve QPP status and obtain an AAPM bonus.  The lack of these incentives will limit the number of practices that will take risks.  The 2023 proposed criteria for an AAPM lists the qualification criteria as “…at least 75 percent of Medicare Part B payments or see at least 50 percent of Medicare patients.”  Cancer care teams treat hematology patients and a wide range of cancers, many more than the seven cancers in the EOM.  Achieving either of the AAPM thresholds will be problematic for some, which would require them to comply with MIPS and EOM criteria.

Recommendations

In light of the concerns detailed in this letter, COA respectfully requests the following changes and considerations as CMMI continues the preparations for and rollout of the EOM.  These will introduce important safeguards for practices and flexibility for their participation in what is potentially a very lopsided risk arrangement.  We believe that these changes will help maximize participation in the EOM.

1. Cancer care teams need to be very thoughtful and deliberate with their decisions to commit to the EOM. They need as much financial information as possible from CMMI as they weigh their options.  This should include care team-specific benchmarks for the first performance period.  These benchmarks should be as complete and accurate as possible, and each team should receive this information a minimum of two weeks before the deadline to commit.
2. A minimum of two full years of either an upside or no risk option for the EOM. This will allow sufficient time for teams to understand the model, as well as an indication of their ability to meet their targets, particularly those teams with no experience with assuming model risk.  A recent survey of COA’s network of practices indicates that only eight percent of the non-OCM participants are interested in the EOM.  The EOM needs to be attractive to cancer centers that were not in the OCM.  A no-risk option would make the EOM more attractive.
3. All participants should be allowed to exit the EOM with a minimum of a 30-day notice. Their performance, whether it be a bonus or a refund for the performance period, should be prorated based on the effective date of their departure from the model.
4. CMMI needs to significantly increase the MEOS payment, especially in the initial phases of EOM implementation, to cover the additional costs, including, but not limited to, SDOH documentation and assistance, staffing, consultant, and interoperability costs of ePROs. Especially in this current environment of inflation and Medicare reimbursement cuts, CMMI cannot ask practices to do more work for less compensation as it is not financially viable.
5. CMMI needs to provide timely, clear, and useful information back to EOM participants so that they can correct deficiencies.   We are concerned that the EOM will not “learn” from a major flaw of the OCM and that information provided by CMMI will be useless due to delays and lack of clarity.
6. CCMI should not limit the EOM to seven cancers, which would exclude some Medicare beneficiaries from participating in the model. Increasing the list to all cancers would assure all Medicare patients with cancer receive high-quality cancer care and would increase the likelihood that the participants in risk arrangement two would qualify as an AAPM.

Conclusion

As it has proven with the OCM, COA wants to work closely with CMMI to ensure the EOM’s success.  We are committed to this, as the CMMI staff well knows.  However, CMMI must make some changes to the EOM design and implementation.   Without changes, we are concerned that the EOM will fail as a demonstration project and as a model that can realistically transform the U.S. cancer care and payment system for the better.

Our recommendation is for CMMI EOM staff to convene a virtual meeting as soon as possible with us and members of our Oncology Payment Reform Committee, who were involved in the preparation of this letter, to discuss our concerns and recommendations.  We are available to set up that virtual meeting ASAP.

Sincerely,

Michael Diaz, MD
Co-Chair, COA Oncology Payment Reform Committee

Lalan Wilfong, MD
Co-Chair, COA Oncology Payment Reform Committee

Bo Gamble
Director of Quality & Value

CC:
Lara Strawbridge
Division Director, Division of Ambulatory Payment Model
Center for Medicare and Medicaid Innovation Center

Hillary Cavanagh
Deputy Division Director, Division of Ambulatory Payment Models
Center for Medicare and Medicaid Innovation Center

1 National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology, adult cancer pain Version 1.2022. NCCN, 2022 https://www.nccn.org/guidelines/category_3

2 National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology, cancer-related fatigue Version 2.2022 NCCN, 2022 https://www.nccn.org/guidelines/category_3

3 Smith, T. G., Troeschel, A. N., Castro, K. M., Arora, N. K., Stein, K., Lipscomb, J., Brawley, O. W., McCabe, R. M., Clauser, S. B., & Ward, E. (2019).  Perceptions of patients with breast and colon cancer of the management of cancer-related pain, fatigue, and emotional distress in community oncology.  Journal of Clinical Oncology, 37(19), 1666-1676.  https://doi.org/10.1200/jco.18.01579

4 Bubis, L. D., Davis, L., Mahar, A., Barbera, L., Li, Q., Moody, L., Karanicolas, P., Sutradhar, R., & Coburn, N. G. (2018).  Symptom burden in the first year after cancer diagnosis: An analysis of patient-reported outcomes.  Journal of Clinical Oncology, 36(11), 1103-1111.  https://doi.org/10.1200/jco.2017.76.0876