Submitted electronically to: http://www.regulations.gov
The Honorable Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00451N
P.O. Box 8013
Baltimore, MD 21244-8013
Re: Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures – Radiation Oncology Model (CMS-5527-P)
Dear Administrator Verma:
On behalf of the Board of Directors of the Community Oncology Alliance (COA), we are submitting this comment letter regarding the Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures – Radiation Oncology Model (CMS-5527-P, referred to herein as the “RO Model”).
As you know, COA is an organization that is 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 non-profit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer. COA’s mission is to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work. For more than 16 years, COA has built a national grassroots network of community oncology practices to advocate for public policies to support patients with cancer.
We appreciate the Centers for Medicare and Medicaid Services’ (CMS’) decision to issue a model focused on radiation oncology. We support CMS’ effort to transition providers out of fee-for-service arrangements and into value-based care solutions that will improve quality of care, lower costs, and enhance patient experience. Value-based care solutions via alternative payment models (APMs) create opportunities for different providers to participate and succeed in unique and dynamic arrangements. The RO Model will fundamentally shift physician reimbursement and incentivize appropriate and timely care. We appreciate CMS’ commitment to increasing the number of APMs for providers to join and increasing the number of specialty focused APMs.
While we are pleased that CMS is moving in the direction of value-based care, we have significant concerns regarding some of the RO Model parameters. We are concerned that the agency’s proposed model will create unnecessary burdens and challenges to physicians. Specifically, our concerns are as follows:
- Mandatory Nature and Scale of the RO Model
- Timing of the RO Model
- Base Rate Methodology
- Episode Stratification and Flexibility
- Discounts, Operations, and Cash Flow Disruption
- Quality Measures and Overlap with Other Models
- Reconciliation Process
We will provide detailed comments on each of these areas in this letter.
Mandatory Nature and Scale of the RO Model:
COA supports the creation and testing of Alternative Payment Models (APMs), particularly Advanced APMs and MIPS APMs, through the CMS Innovation Center (CMMI). However, we are concerned with the mandatory participation element of the RO Model. In general, we do not believe mandatory models are appropriate given the operational challenges associated with joining and participating in an APM. It is important to give providers the choice to join an APM because not all providers have the infrastructure, commitment, and organizational buy-in to succeed in new payment arrangements. If required to participate, providers may not have adequate support to achieve the model’s desired goals while ensuring they continue to meet the needs of their patients.
As we have detailed in the past, COA believes that mandatory demonstration projects are not in the charter of CMMI as written into law by Congress. While CMMI is meant to serve as an incubator for payment and delivery reform ideas, it should not implement models that fundamentally and effectively change Medicare reimbursement policies.
The RO Model, as proposed, is another complex and transformative demonstration developed by CMMI, with potentially broad geographic reach and strong potential to disrupt the cancer care delivery system. COA is staunchly opposed to mandatory models, especially of the scale and complexity outlined as part of the RO Model. The RO Model establishes a “demonstration” of the size and scope that far exceeds anything that can be reasonably considered a “test.”
COA’s legal and constitutional reasons for our opposition to mandatory CMMI demonstration projects are summarized as follows:
- The RO Model as Proposed Exceeds CMS’ Statutory Authority. In mandating a model, CMS will undoubtedly rely on Section 1115A of the Patient Protection and Affordable Care Act (“ACA”). The RO Model as proposed exceeds CMS’ authority because, among other reasons: (A) the RO Model is inconsistent with the express mandate of Section 1115A; (B) the RO Model – by being mandatory in scope and potentially affecting a large portion of the nation – is not a test or model; and (C) the RO Model appears not to be based upon a model developed by CMMI, but rather one developed outside of CMMI.
- The Secretary Has No Authority to Waive Medicare Provisions Under the RO Model. As the RO Model fails to meet the requirements for “testing,” the Secretary has no authority to waive any requirements of the Medicare statute.
- The RO Model Contravenes Other Applicable Laws. The RO Model violates Section 3601 of the ACA, as the implementation of the model would affect guaranteed Medicare benefits and other provisions.
It is important to note that other models, such as the Bundled Payments for Care Improvement Advanced (BPCI Model) and the Oncology Care Model (OCM), are voluntary models and have significant provider interest and participation. As such, we believe models do not need to be mandatory in order to garner interest and participation. The RO Model fundamentally restructures the reimbursement model for radiation oncologists, so it is vital for CMMI to first test the model – as a true test – and collect data on results prior to considering a larger scale model, certainly one that is far reaching and mandatory.
COA is also concerned with the scale of the RO Model. CMS proposes to include 40 percent of all episodes nationwide and 17 cancer types in the model. We believe this is excessive. Radiation oncologists first need to understand the mechanics of the model on a smaller scale prior to any large-scale implementation. As such, if CMS continues with a mandatory model, we urge CMS to consider testing the RO Model on a smaller scale with fewer participants and cancer types and then analyze performance data prior to an increase in scope.
CMMI should be working closely with COA and other organizations to develop the RO Model into one that will first test and then implement the model on a broader scale. We strongly believe that no provider should be forced into any transformative model.
Recommendation:
- We recommend that CMS make the RO Model a voluntary program for radiation oncologists. In addition, we recommend that CMS reduce the number of cancer types included in the model and instead collect and analyze performance data prior to any large-scale implementation.
Timing of the RO Model:
Participation in alternative payment models is both challenging and time consuming. Practices need to invest time and resources prior to the start of the model and continue to do so throughout their participation in order to achieve success. COA is concerned that the proposed start date of the RO Model does not give practices enough time to make the necessary practice transformation changes and will therefore result in many operational challenges for radiation oncologists. Furthermore, because this model restructures reimbursement for physicians there will need to be additional time to understand the implications of this change.
Recommendation:
- Instead of having the model start on January 1, 2020, we recommend that the model start on August 1, 2020. To create the most efficient and effective rollout and start to the RO Model, CMS must give providers more time to understand how the model will affect their practices and what investments must be made in order to succeed in the model.
Base Rate Methodology:
COA appreciates CMS’ detailed methodology for calculating the professional component (PC) and technical component (TC) payments to radiation oncologists. However, for this model to succeed, it is vital to set accurate and appropriate rates which ensures the reimbursement is accurate for all providers, regardless of the site of care in which they practice.
COA’s primary concern with the base rate methodology is the use of Hospital Outpatient Department (HOPD) episodes only. According to CMS’ analysis, HOPDs furnished 64 percent of episodes nationwide from January 1, 2015, to December 31, 2017. Although HOPDs furnished the plurality of episodes, CMS’ methodology does not include all episodes, which weakens the overall structure of the RO Model. Furthermore, CMS’ analysis suggests that PFS episodes utilize IMRT to a greater extent, however the claims analysis provides no basis to suggest that such utilization is not medically necessary.
We appreciate CMS’ inclusion of the Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) trends in the trend factor calculation; however, given our experience with the OCM, we remain concerned about the utilization of a trend factor in general, and seek to ensure that the base rates are updated in a manner that fully accounts for changes in the cost of care. We believe it is important for the base rate methodology to also include OPPS and PFS episodes because it will create more accurate and fair payments prior to the application of the trend factor in the payment methodology.
Recommendation:
- Instead of calculating base rates on HOPD episodes only, we strongly recommend that CMS also include PFS episodes. By including all episodes (i.e., HOPD and PFS episodes) in the base rate calculation, CMS will include a greater patient population which will in turn reflect more accurate payments to physicians. In addition, by revising the base rate calculation, CMS will account for different care patterns based on a greater patient mix, which will create more fair and appropriate payments to physicians.
Episode Stratification and Flexibility:
COA acknowledges and appreciates CMS’ commitment to innovative payment arrangements in Medicare. However, we are concerned with the proposed capitated arrangement. Specifically, we believe that the capitated system creates a lack of flexibility for different practices with different patient populations. It is important for CMS to consider the stages of diseases for different cancer types when calculating payments to physicians.
Recommendation:
- Because there are notable differences in the treatment approach for patients with stage 1 cancer versus stage 4 cancer, we recommend that CMS create different payments based on a practice’s patient risk levels. Although CMS adjusts the base rate for a physician’s historical case mix, the model does not set separate reimbursement rates for different types of patients. Like the OCM, we recommend that CMS create a “high-risk” and a “low-risk” cohort for certain cancer types (e.g., breast, prostate, and lung). By stratifying within cancer types, CMS will create more accurate and fair payments to physicians.
In addition to appropriate stratification, we believe it is important to create a flexible model that accounts for changes in the health care system. Importantly, CMS must consider how to account for changes in technology and innovation in radiation oncology.
Recommendation:
- We urge CMS to ensure that the RO Model does not stop new techniques and approaches to treatment from being utilized simply because it is not accounted for in the payment methodology. To account for new techniques and treatment approaches, CMS could take a similar approach to the novel therapy adjustment (NTA) in the OCM. Under this approach, CMS could calculate average spending for a new treatment (or a new application of an existing advanced radiotherapy technique) and if a practice spends more than a comparison group, the difference could be included in the Professional Component (PC) and Technical Component (TC) payments.
Discounts, Operations, and Cash Flow Disruption:
In addition to all the withholds, CMS proposes a 5 percent TC discount. We believe the 5 percent TC discount serves policy purposes beyond guaranteeing savings for CMS. Radiation oncology facilities incur significant capital costs in establishing and maintaining state of the art radiotherapy technology (including vault construction, radiation shielding, equipment servicing), we believe the 5 percent discount will only create more challenges for physicians. Discounting technical payments may adversely impact quality of care and is not consistent with the goals of this model. Radiation oncologists must have an appropriate flow of payments to operate and maintain technology needed to help patients and improve outcomes. There are several examples of technologies that radiation facilities employ which are critical for patient care. Facilities rely on technical payments to invest in these technologies, which actually increases the value of care by decreasing long term toxicity to patients. A prime example is the utilization of deep inspiration breath hold technology to significantly decrease risks of late cardiac toxicity in patients undergoing breast radiotherapy.
Recommendation:
- We recommend that CMS eliminate the 5 percent TC discount because it may otherwise have severe adverse consequences on radiation therapy centers, especially those who serve a disproportionally large Medicare population, particularly in underserved and rural areas.
For providers to succeed in this model, CMS must provide frequent data to participants. We believe it is important to receive data on a regular basis so participants can track patients, analyze performance, and identify opportunities for improvement.
Recommendation:
- We recommend that CMS provide RO Model participants data on a monthly basis. Participants in other models, such as BPCI Advanced, receive monthly data feeds and we believe this should be the standard for all APMs. If CMS would like providers to take on more risk at a quicker pace, it is important to provide as many resources to participants as possible and consistent data is one resource that can result in notable and impactful change.
CMS proposes to withhold a portion of the base rate for interrupted/incomplete episodes (2 percent withholding for the PC and TC). Although we understand CMS’ rationale for withholding payments upfront, we believe that by splitting payment at the beginning and end of episodes, physicians will already need to manage their finances to ensure appropriate cash flow. As such, we are concerned that further reducing these payments will create unnecessary burdens for providers. Many providers will not have the cash flow necessary to wait until reconciliation to receive these payments.
In addition, we are concerned with the 1 percent TC withholding for patient experience beginning in performance year three. Patient experience is based on surveys that are mailed out and have varied response rates. For many practices, especially those in rural areas or with a lower socioeconomic patient population, patient experience surveys do not adequately capture performance. As such, we believe that a 1 percent withholding is unreasonable and should only serve as supplemental data collection.
Recommendation:
- We recommend that CMS eliminate the 2 percent interrupted/incomplete episode withholding because prospective payments are already split at the beginning and end of episodes. In addition, we recommend that radiation therapy’s Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey data be collected as supplemental data for at least one year prior to any withholdings associated with patient experience.
Quality Measures and Overlap with Other Models:
COA supports the inclusion of quality measures in APMs. We believe it is important to incorporate quality guardrails and measurements to ensure the delivery of high-quality care. Generally, we support CMS’ proposed quality measures; however, because patients already receive survivorship care plans, we believe the CMS quality measure for a care plan is duplicative and should be considered for modification or removal. CMS is focused on streamlining quality programs and focusing on a smaller number of meaningful measures and we believe modifying or removing this measure provides an opportunity to support CMS’ goal. COA also supports measures and processes that reduce the administrative burden for practices. Typically, models require practices to keep records for 10 years; however, to create less administrative burden for practices, we believe practices should only be required to keep records for 6 years.
Recommendation:
- We recommend that CMS either remove or modify the care plan quality measure to remove duplicative processes. To alleviate provider burden, we also recommend that CMS require practices to keep records for only 6 years.
With the creation of more APMs, CMS must consider how these models will interact with one another and what this means for participation in different models. Oncologists, including radiation oncologists, are eligible to participate in the OCM, which is similarly focused on oncology care. Providers participating in the OCM have already invested in practice transformation, including learning about the model, modifying care processes, and navigating successes and challenges. CMS would like to transition as many providers to APMs as possible. Therefore, CMS should focus on supporting providers currently not participating in an APM and encouraging these providers to participate, rather than requiring some providers to participate, in a second model, especially without any clarity on how these models may interact. We support CMS’ goal to transition providers to risk-bearing programs and believe CMS will most effectively achieve this goal by focusing on providers not currently participating.
Recommendation:
We recommend that CMS exempt OCM practices from participating in the RO Model. Greater clarity is needed on how such models may interact before mandating organizations and providers participate in multiple models. Instead, we encourage CMS to find ways to encourage providers currently not in an APM to join new payment models.
Reconciliation Process:
COA appreciates the opportunity to review reconciliation results and submit potential errors to CMS. However, we are concerned that a 30-day window for review and submission is insufficient to fully understand the details of the reconciliation report, assess potential errors, and work with CMS to address potential errors. In addition, COA is concerned that the true-up process unnecessarily extends the process and could create potential cashflow issues for practices.
Recommendation:
- To give practices additional time to review data and to not interfere with cash flow mechanisms, COA recommends that CMS provides a 90-day period for practices to review their reconciliation data and file an error report to CMS. In addition, COA recommends eliminating the true-up process and adhering to the reconciliation process given that most claims are submitted and completed within a reasonable timeframe relative to the episode of care.
Conclusion
COA appreciates the opportunity to comment on this proposed radiation oncology APM and looks forward to discussing it with you further. We are extremely willing to work with the administration to ensure the final RO Model is appropriately flexible for patients and qualified providers, including community oncologists, and that it results in high-quality, low-cost care, and enhanced patient experiences for all patients included in the model.
Please do not hesitate to reach out with any questions.
Sincerely,
Anshu Jain, MD
Chair, COA Radiation Therapy Task Force
Michael Diaz, MD
President
Ted Okon
Executive Director
COA Formal Comments to CMS on Proposed Radiation Oncology Alternative Payment Model (RO Model)
Submitted electronically to: http://www.regulations.gov
The Honorable Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00451N
P.O. Box 8013
Baltimore, MD 21244-8013
Re: Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures – Radiation Oncology Model (CMS-5527-P)
Dear Administrator Verma:
On behalf of the Board of Directors of the Community Oncology Alliance (COA), we are submitting this comment letter regarding the Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures – Radiation Oncology Model (CMS-5527-P, referred to herein as the “RO Model”).
As you know, COA is an organization that is 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 non-profit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer. COA’s mission is to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work. For more than 16 years, COA has built a national grassroots network of community oncology practices to advocate for public policies to support patients with cancer.
We appreciate the Centers for Medicare and Medicaid Services’ (CMS’) decision to issue a model focused on radiation oncology. We support CMS’ effort to transition providers out of fee-for-service arrangements and into value-based care solutions that will improve quality of care, lower costs, and enhance patient experience. Value-based care solutions via alternative payment models (APMs) create opportunities for different providers to participate and succeed in unique and dynamic arrangements. The RO Model will fundamentally shift physician reimbursement and incentivize appropriate and timely care. We appreciate CMS’ commitment to increasing the number of APMs for providers to join and increasing the number of specialty focused APMs.
While we are pleased that CMS is moving in the direction of value-based care, we have significant concerns regarding some of the RO Model parameters. We are concerned that the agency’s proposed model will create unnecessary burdens and challenges to physicians. Specifically, our concerns are as follows:
We will provide detailed comments on each of these areas in this letter.
Mandatory Nature and Scale of the RO Model:
COA supports the creation and testing of Alternative Payment Models (APMs), particularly Advanced APMs and MIPS APMs, through the CMS Innovation Center (CMMI). However, we are concerned with the mandatory participation element of the RO Model. In general, we do not believe mandatory models are appropriate given the operational challenges associated with joining and participating in an APM. It is important to give providers the choice to join an APM because not all providers have the infrastructure, commitment, and organizational buy-in to succeed in new payment arrangements. If required to participate, providers may not have adequate support to achieve the model’s desired goals while ensuring they continue to meet the needs of their patients.
As we have detailed in the past, COA believes that mandatory demonstration projects are not in the charter of CMMI as written into law by Congress. While CMMI is meant to serve as an incubator for payment and delivery reform ideas, it should not implement models that fundamentally and effectively change Medicare reimbursement policies.
The RO Model, as proposed, is another complex and transformative demonstration developed by CMMI, with potentially broad geographic reach and strong potential to disrupt the cancer care delivery system. COA is staunchly opposed to mandatory models, especially of the scale and complexity outlined as part of the RO Model. The RO Model establishes a “demonstration” of the size and scope that far exceeds anything that can be reasonably considered a “test.”
COA’s legal and constitutional reasons for our opposition to mandatory CMMI demonstration projects are summarized as follows:
It is important to note that other models, such as the Bundled Payments for Care Improvement Advanced (BPCI Model) and the Oncology Care Model (OCM), are voluntary models and have significant provider interest and participation. As such, we believe models do not need to be mandatory in order to garner interest and participation. The RO Model fundamentally restructures the reimbursement model for radiation oncologists, so it is vital for CMMI to first test the model – as a true test – and collect data on results prior to considering a larger scale model, certainly one that is far reaching and mandatory.
COA is also concerned with the scale of the RO Model. CMS proposes to include 40 percent of all episodes nationwide and 17 cancer types in the model. We believe this is excessive. Radiation oncologists first need to understand the mechanics of the model on a smaller scale prior to any large-scale implementation. As such, if CMS continues with a mandatory model, we urge CMS to consider testing the RO Model on a smaller scale with fewer participants and cancer types and then analyze performance data prior to an increase in scope.
CMMI should be working closely with COA and other organizations to develop the RO Model into one that will first test and then implement the model on a broader scale. We strongly believe that no provider should be forced into any transformative model.
Recommendation:
Timing of the RO Model:
Participation in alternative payment models is both challenging and time consuming. Practices need to invest time and resources prior to the start of the model and continue to do so throughout their participation in order to achieve success. COA is concerned that the proposed start date of the RO Model does not give practices enough time to make the necessary practice transformation changes and will therefore result in many operational challenges for radiation oncologists. Furthermore, because this model restructures reimbursement for physicians there will need to be additional time to understand the implications of this change.
Recommendation:
Base Rate Methodology:
COA appreciates CMS’ detailed methodology for calculating the professional component (PC) and technical component (TC) payments to radiation oncologists. However, for this model to succeed, it is vital to set accurate and appropriate rates which ensures the reimbursement is accurate for all providers, regardless of the site of care in which they practice.
COA’s primary concern with the base rate methodology is the use of Hospital Outpatient Department (HOPD) episodes only. According to CMS’ analysis, HOPDs furnished 64 percent of episodes nationwide from January 1, 2015, to December 31, 2017. Although HOPDs furnished the plurality of episodes, CMS’ methodology does not include all episodes, which weakens the overall structure of the RO Model. Furthermore, CMS’ analysis suggests that PFS episodes utilize IMRT to a greater extent, however the claims analysis provides no basis to suggest that such utilization is not medically necessary.
We appreciate CMS’ inclusion of the Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) trends in the trend factor calculation; however, given our experience with the OCM, we remain concerned about the utilization of a trend factor in general, and seek to ensure that the base rates are updated in a manner that fully accounts for changes in the cost of care. We believe it is important for the base rate methodology to also include OPPS and PFS episodes because it will create more accurate and fair payments prior to the application of the trend factor in the payment methodology.
Recommendation:
Episode Stratification and Flexibility:
COA acknowledges and appreciates CMS’ commitment to innovative payment arrangements in Medicare. However, we are concerned with the proposed capitated arrangement. Specifically, we believe that the capitated system creates a lack of flexibility for different practices with different patient populations. It is important for CMS to consider the stages of diseases for different cancer types when calculating payments to physicians.
Recommendation:
In addition to appropriate stratification, we believe it is important to create a flexible model that accounts for changes in the health care system. Importantly, CMS must consider how to account for changes in technology and innovation in radiation oncology.
Recommendation:
Discounts, Operations, and Cash Flow Disruption:
In addition to all the withholds, CMS proposes a 5 percent TC discount. We believe the 5 percent TC discount serves policy purposes beyond guaranteeing savings for CMS. Radiation oncology facilities incur significant capital costs in establishing and maintaining state of the art radiotherapy technology (including vault construction, radiation shielding, equipment servicing), we believe the 5 percent discount will only create more challenges for physicians. Discounting technical payments may adversely impact quality of care and is not consistent with the goals of this model. Radiation oncologists must have an appropriate flow of payments to operate and maintain technology needed to help patients and improve outcomes. There are several examples of technologies that radiation facilities employ which are critical for patient care. Facilities rely on technical payments to invest in these technologies, which actually increases the value of care by decreasing long term toxicity to patients. A prime example is the utilization of deep inspiration breath hold technology to significantly decrease risks of late cardiac toxicity in patients undergoing breast radiotherapy.
Recommendation:
For providers to succeed in this model, CMS must provide frequent data to participants. We believe it is important to receive data on a regular basis so participants can track patients, analyze performance, and identify opportunities for improvement.
Recommendation:
CMS proposes to withhold a portion of the base rate for interrupted/incomplete episodes (2 percent withholding for the PC and TC). Although we understand CMS’ rationale for withholding payments upfront, we believe that by splitting payment at the beginning and end of episodes, physicians will already need to manage their finances to ensure appropriate cash flow. As such, we are concerned that further reducing these payments will create unnecessary burdens for providers. Many providers will not have the cash flow necessary to wait until reconciliation to receive these payments.
In addition, we are concerned with the 1 percent TC withholding for patient experience beginning in performance year three. Patient experience is based on surveys that are mailed out and have varied response rates. For many practices, especially those in rural areas or with a lower socioeconomic patient population, patient experience surveys do not adequately capture performance. As such, we believe that a 1 percent withholding is unreasonable and should only serve as supplemental data collection.
Recommendation:
Quality Measures and Overlap with Other Models:
COA supports the inclusion of quality measures in APMs. We believe it is important to incorporate quality guardrails and measurements to ensure the delivery of high-quality care. Generally, we support CMS’ proposed quality measures; however, because patients already receive survivorship care plans, we believe the CMS quality measure for a care plan is duplicative and should be considered for modification or removal. CMS is focused on streamlining quality programs and focusing on a smaller number of meaningful measures and we believe modifying or removing this measure provides an opportunity to support CMS’ goal. COA also supports measures and processes that reduce the administrative burden for practices. Typically, models require practices to keep records for 10 years; however, to create less administrative burden for practices, we believe practices should only be required to keep records for 6 years.
Recommendation:
With the creation of more APMs, CMS must consider how these models will interact with one another and what this means for participation in different models. Oncologists, including radiation oncologists, are eligible to participate in the OCM, which is similarly focused on oncology care. Providers participating in the OCM have already invested in practice transformation, including learning about the model, modifying care processes, and navigating successes and challenges. CMS would like to transition as many providers to APMs as possible. Therefore, CMS should focus on supporting providers currently not participating in an APM and encouraging these providers to participate, rather than requiring some providers to participate, in a second model, especially without any clarity on how these models may interact. We support CMS’ goal to transition providers to risk-bearing programs and believe CMS will most effectively achieve this goal by focusing on providers not currently participating.
Recommendation:
We recommend that CMS exempt OCM practices from participating in the RO Model. Greater clarity is needed on how such models may interact before mandating organizations and providers participate in multiple models. Instead, we encourage CMS to find ways to encourage providers currently not in an APM to join new payment models.
Reconciliation Process:
COA appreciates the opportunity to review reconciliation results and submit potential errors to CMS. However, we are concerned that a 30-day window for review and submission is insufficient to fully understand the details of the reconciliation report, assess potential errors, and work with CMS to address potential errors. In addition, COA is concerned that the true-up process unnecessarily extends the process and could create potential cashflow issues for practices.
Recommendation:
Conclusion
COA appreciates the opportunity to comment on this proposed radiation oncology APM and looks forward to discussing it with you further. We are extremely willing to work with the administration to ensure the final RO Model is appropriately flexible for patients and qualified providers, including community oncologists, and that it results in high-quality, low-cost care, and enhanced patient experiences for all patients included in the model.
Please do not hesitate to reach out with any questions.
Sincerely,
Anshu Jain, MD
Chair, COA Radiation Therapy Task Force
Michael Diaz, MD
President
Ted Okon
Executive Director
COA Formal Comments to CMS on Proposed Radiation Oncology Alternative Payment Model (RO Model)
Submitted electronically to: http://www.regulations.gov
The Honorable Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00451N
P.O. Box 8013
Baltimore, MD 21244-8013
Re: Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures – Radiation Oncology Model (CMS-5527-P)
Dear Administrator Verma:
On behalf of the Board of Directors of the Community Oncology Alliance (COA), we are submitting this comment letter regarding the Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures – Radiation Oncology Model (CMS-5527-P, referred to herein as the “RO Model”).
As you know, COA is an organization that is 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 non-profit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer. COA’s mission is to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work. For more than 16 years, COA has built a national grassroots network of community oncology practices to advocate for public policies to support patients with cancer.
We appreciate the Centers for Medicare and Medicaid Services’ (CMS’) decision to issue a model focused on radiation oncology. We support CMS’ effort to transition providers out of fee-for-service arrangements and into value-based care solutions that will improve quality of care, lower costs, and enhance patient experience. Value-based care solutions via alternative payment models (APMs) create opportunities for different providers to participate and succeed in unique and dynamic arrangements. The RO Model will fundamentally shift physician reimbursement and incentivize appropriate and timely care. We appreciate CMS’ commitment to increasing the number of APMs for providers to join and increasing the number of specialty focused APMs.
While we are pleased that CMS is moving in the direction of value-based care, we have significant concerns regarding some of the RO Model parameters. We are concerned that the agency’s proposed model will create unnecessary burdens and challenges to physicians. Specifically, our concerns are as follows:
We will provide detailed comments on each of these areas in this letter.
Mandatory Nature and Scale of the RO Model:
COA supports the creation and testing of Alternative Payment Models (APMs), particularly Advanced APMs and MIPS APMs, through the CMS Innovation Center (CMMI). However, we are concerned with the mandatory participation element of the RO Model. In general, we do not believe mandatory models are appropriate given the operational challenges associated with joining and participating in an APM. It is important to give providers the choice to join an APM because not all providers have the infrastructure, commitment, and organizational buy-in to succeed in new payment arrangements. If required to participate, providers may not have adequate support to achieve the model’s desired goals while ensuring they continue to meet the needs of their patients.
As we have detailed in the past, COA believes that mandatory demonstration projects are not in the charter of CMMI as written into law by Congress. While CMMI is meant to serve as an incubator for payment and delivery reform ideas, it should not implement models that fundamentally and effectively change Medicare reimbursement policies.
The RO Model, as proposed, is another complex and transformative demonstration developed by CMMI, with potentially broad geographic reach and strong potential to disrupt the cancer care delivery system. COA is staunchly opposed to mandatory models, especially of the scale and complexity outlined as part of the RO Model. The RO Model establishes a “demonstration” of the size and scope that far exceeds anything that can be reasonably considered a “test.”
COA’s legal and constitutional reasons for our opposition to mandatory CMMI demonstration projects are summarized as follows:
It is important to note that other models, such as the Bundled Payments for Care Improvement Advanced (BPCI Model) and the Oncology Care Model (OCM), are voluntary models and have significant provider interest and participation. As such, we believe models do not need to be mandatory in order to garner interest and participation. The RO Model fundamentally restructures the reimbursement model for radiation oncologists, so it is vital for CMMI to first test the model – as a true test – and collect data on results prior to considering a larger scale model, certainly one that is far reaching and mandatory.
COA is also concerned with the scale of the RO Model. CMS proposes to include 40 percent of all episodes nationwide and 17 cancer types in the model. We believe this is excessive. Radiation oncologists first need to understand the mechanics of the model on a smaller scale prior to any large-scale implementation. As such, if CMS continues with a mandatory model, we urge CMS to consider testing the RO Model on a smaller scale with fewer participants and cancer types and then analyze performance data prior to an increase in scope.
CMMI should be working closely with COA and other organizations to develop the RO Model into one that will first test and then implement the model on a broader scale. We strongly believe that no provider should be forced into any transformative model.
Recommendation:
Timing of the RO Model:
Participation in alternative payment models is both challenging and time consuming. Practices need to invest time and resources prior to the start of the model and continue to do so throughout their participation in order to achieve success. COA is concerned that the proposed start date of the RO Model does not give practices enough time to make the necessary practice transformation changes and will therefore result in many operational challenges for radiation oncologists. Furthermore, because this model restructures reimbursement for physicians there will need to be additional time to understand the implications of this change.
Recommendation:
Base Rate Methodology:
COA appreciates CMS’ detailed methodology for calculating the professional component (PC) and technical component (TC) payments to radiation oncologists. However, for this model to succeed, it is vital to set accurate and appropriate rates which ensures the reimbursement is accurate for all providers, regardless of the site of care in which they practice.
COA’s primary concern with the base rate methodology is the use of Hospital Outpatient Department (HOPD) episodes only. According to CMS’ analysis, HOPDs furnished 64 percent of episodes nationwide from January 1, 2015, to December 31, 2017. Although HOPDs furnished the plurality of episodes, CMS’ methodology does not include all episodes, which weakens the overall structure of the RO Model. Furthermore, CMS’ analysis suggests that PFS episodes utilize IMRT to a greater extent, however the claims analysis provides no basis to suggest that such utilization is not medically necessary.
We appreciate CMS’ inclusion of the Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) trends in the trend factor calculation; however, given our experience with the OCM, we remain concerned about the utilization of a trend factor in general, and seek to ensure that the base rates are updated in a manner that fully accounts for changes in the cost of care. We believe it is important for the base rate methodology to also include OPPS and PFS episodes because it will create more accurate and fair payments prior to the application of the trend factor in the payment methodology.
Recommendation:
Episode Stratification and Flexibility:
COA acknowledges and appreciates CMS’ commitment to innovative payment arrangements in Medicare. However, we are concerned with the proposed capitated arrangement. Specifically, we believe that the capitated system creates a lack of flexibility for different practices with different patient populations. It is important for CMS to consider the stages of diseases for different cancer types when calculating payments to physicians.
Recommendation:
In addition to appropriate stratification, we believe it is important to create a flexible model that accounts for changes in the health care system. Importantly, CMS must consider how to account for changes in technology and innovation in radiation oncology.
Recommendation:
Discounts, Operations, and Cash Flow Disruption:
In addition to all the withholds, CMS proposes a 5 percent TC discount. We believe the 5 percent TC discount serves policy purposes beyond guaranteeing savings for CMS. Radiation oncology facilities incur significant capital costs in establishing and maintaining state of the art radiotherapy technology (including vault construction, radiation shielding, equipment servicing), we believe the 5 percent discount will only create more challenges for physicians. Discounting technical payments may adversely impact quality of care and is not consistent with the goals of this model. Radiation oncologists must have an appropriate flow of payments to operate and maintain technology needed to help patients and improve outcomes. There are several examples of technologies that radiation facilities employ which are critical for patient care. Facilities rely on technical payments to invest in these technologies, which actually increases the value of care by decreasing long term toxicity to patients. A prime example is the utilization of deep inspiration breath hold technology to significantly decrease risks of late cardiac toxicity in patients undergoing breast radiotherapy.
Recommendation:
For providers to succeed in this model, CMS must provide frequent data to participants. We believe it is important to receive data on a regular basis so participants can track patients, analyze performance, and identify opportunities for improvement.
Recommendation:
CMS proposes to withhold a portion of the base rate for interrupted/incomplete episodes (2 percent withholding for the PC and TC). Although we understand CMS’ rationale for withholding payments upfront, we believe that by splitting payment at the beginning and end of episodes, physicians will already need to manage their finances to ensure appropriate cash flow. As such, we are concerned that further reducing these payments will create unnecessary burdens for providers. Many providers will not have the cash flow necessary to wait until reconciliation to receive these payments.
In addition, we are concerned with the 1 percent TC withholding for patient experience beginning in performance year three. Patient experience is based on surveys that are mailed out and have varied response rates. For many practices, especially those in rural areas or with a lower socioeconomic patient population, patient experience surveys do not adequately capture performance. As such, we believe that a 1 percent withholding is unreasonable and should only serve as supplemental data collection.
Recommendation:
Quality Measures and Overlap with Other Models:
COA supports the inclusion of quality measures in APMs. We believe it is important to incorporate quality guardrails and measurements to ensure the delivery of high-quality care. Generally, we support CMS’ proposed quality measures; however, because patients already receive survivorship care plans, we believe the CMS quality measure for a care plan is duplicative and should be considered for modification or removal. CMS is focused on streamlining quality programs and focusing on a smaller number of meaningful measures and we believe modifying or removing this measure provides an opportunity to support CMS’ goal. COA also supports measures and processes that reduce the administrative burden for practices. Typically, models require practices to keep records for 10 years; however, to create less administrative burden for practices, we believe practices should only be required to keep records for 6 years.
Recommendation:
With the creation of more APMs, CMS must consider how these models will interact with one another and what this means for participation in different models. Oncologists, including radiation oncologists, are eligible to participate in the OCM, which is similarly focused on oncology care. Providers participating in the OCM have already invested in practice transformation, including learning about the model, modifying care processes, and navigating successes and challenges. CMS would like to transition as many providers to APMs as possible. Therefore, CMS should focus on supporting providers currently not participating in an APM and encouraging these providers to participate, rather than requiring some providers to participate, in a second model, especially without any clarity on how these models may interact. We support CMS’ goal to transition providers to risk-bearing programs and believe CMS will most effectively achieve this goal by focusing on providers not currently participating.
Recommendation:
We recommend that CMS exempt OCM practices from participating in the RO Model. Greater clarity is needed on how such models may interact before mandating organizations and providers participate in multiple models. Instead, we encourage CMS to find ways to encourage providers currently not in an APM to join new payment models.
Reconciliation Process:
COA appreciates the opportunity to review reconciliation results and submit potential errors to CMS. However, we are concerned that a 30-day window for review and submission is insufficient to fully understand the details of the reconciliation report, assess potential errors, and work with CMS to address potential errors. In addition, COA is concerned that the true-up process unnecessarily extends the process and could create potential cashflow issues for practices.
Recommendation:
Conclusion
COA appreciates the opportunity to comment on this proposed radiation oncology APM and looks forward to discussing it with you further. We are extremely willing to work with the administration to ensure the final RO Model is appropriately flexible for patients and qualified providers, including community oncologists, and that it results in high-quality, low-cost care, and enhanced patient experiences for all patients included in the model.
Please do not hesitate to reach out with any questions.
Sincerely,
Anshu Jain, MD
Chair, COA Radiation Therapy Task Force
Michael Diaz, MD
President
Ted Okon
Executive Director