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«Filed electronically on 6/27/16 via June 27, 2016 Mr. Andy Slavitt, Acting Administrator Centers for Medicare & Medicaid ...»

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Filed electronically on 6/27/16 via http://www.regulations.gov

June 27, 2016

Mr. Andy Slavitt, Acting Administrator

Centers for Medicare & Medicaid Services

Department of Health and Human Services

Attention: CMS-5517-P

Mail Stop C4-26-05

7500 Security Boulevard

Baltimore, MD 21244-1850

Re: Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative

Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-

Focused Payment Models – CMS-5517-P

Dear Acting Commissioner Slavitt:

I am the President of the Community Oncology Alliance (COA), a non-profit organization advocating for community oncology practices and, most importantly, the patients they treat. On behalf of the COA Board of Directors, I am submitting comments on the proposed rule published by the Centers for Medicare & Medicaid Services (CMS), Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models – CMS-5517-P (collectively the “Proposed Rule”).

COA is committed to enhancing the quality of cancer care while also making it more cost- effective and affordable, particularly for patients. Over the past five (5) years, COA has been working with Congress and the committees of Medicare jurisdiction, private payers, self-insured employers, and other cancer organizations on oncology payment reform tied to COA’s Oncology Medical Home (OMH) model of care. A steering committee comprised of payers, oncology providers, patient advocates, and industry representatives have developed and endorsed specific measures of cancer care quality and value. We have worked with the American College of Surgeons’ Commission on Cancer on an OMH accreditation program that was successfully piloted in community oncology practices, resulting in ten (10) of the practices receiving full accreditation.

COA has also developed a patient satisfaction survey based on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey that was developed by the Agency for Healthcare Research and Quality (AHRQ). Our survey has been widely utilized, with close to 80,000 completed surveys to date, and helps bring the sentiment of the patient back to the provider, allowing the provider to better identify areas that need to be improved. They query the patient on their experience, something that is not frequently done. Patient responses are not just filed away having “checked the box” as some Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys sent after a hospital experience, but rather are taken very seriously by every member of the cancer care delivery team. That is because feedback on patient and family experience is crucial to a positive outcome. One of the most important measurements is how cancer patients and their support team perceive the access, ability, and affability of their care team. COA’s patient satisfaction survey standardizes this measurement and allows cancer centers to compare themselves to each other by similar size or location. We sincerely hope that CMS/CMMI will consider the use of this survey in its Oncology Care Model (OCM) moving forward. It is a recognized resource for OMH accreditation by the Commission on Cancer and worthy of serious consideration.

In conjunction with our efforts related to the OMH, a COA task force of community oncologists and practice administrators developed, and thoroughly tested, an oncology payment reform model, which ties to the endorsed quality and value measures. Those measures, as well as the payment model, are being used by providers and private payers in pilot programs across the country. Representatives Cathy McMorris Rodgers (R-WA) and Steve Israel (DNY) have sponsored the bipartisan Cancer Care Payment Reform Act of 2015 (H.R. 1934), which incorporates many OMH concepts and associated payment reform model.

Our work continues. On October 25, 2016, in the DC area, COA will host another in a series of summits on oncology payment reform. Bringing together community oncology providers, employers, and private insurers, we will host a discussion on what is working and what is not in oncology payment reform. The summit will feature providers and payers discussing the launch of the OCM by the Center for Medicare and Medicaid Innovation (CMMI), which, as you know, will commence July 1, 2016. COA is working with community oncology practices—both independent and hospital-affiliated—in preparing for and implementing the OCM. We are providing free resources to the participants and networking them together to share information and best practices.

Clearly, community oncology is leading the way with oncology quality improvement and payment reform, and COA’s work and accomplishments in this area speak for themselves.

We appreciate CMS’ vast undertaking in the Proposed Rule to operationalize the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This is indeed, a landmark law in transforming the nation’s healthcare system. We have supported the development of MACRA by sharing COA’s work on the OMH and associated payment reform model with the congressional committees of jurisdiction, as well as CMS and CMMI staff. COA believes that the law will transform health care delivery by putting an increased focus on quality and value and encouraging participation in APMs.

The enormity and detail in the Proposed Rule come at a time when COA has been immersed in working with private payers on the OMH and the associated payment reform model; reaching out to employers on oncology payment reform; helping selected practices sign their agreements and prepare for the OCM; and deal with the Medicare Part B Drug Purchasing Model (the “Part B Model”), which COA believes is a step backwards in CMS and CMMI working cooperatively with community oncology practices. As a result, it has been extremely difficult to analyze all of the detail in the Proposed Rule for both COA and individual oncology practices. Therefore, in this letter, we are providing

CMS with several overarching comments that we, please, ask the agency to consider as follows:

1) We highly recommend that CMS next publish a refined interim final rule, rather than proceeding directly to a final rule;

2) We also highly recommend that the baseline measurement year be pushed back from January 1, 2017, until January 1, 2018; and

3) We request that CMS include all of the OCM practices initially in the APM arm, as well as practices participating in OMH models.

The detail on these recommendations and requests follow. Additionally, we provide other specific comments and questions to CMS on MIPS and APMs.

Recommendation 1: Publish a refined interim final rule with an additional sixty (60) day comment period.

As we related previously in this letter, we appreciate the enormity of the task CMS is undertaking in operationalizing MACRA. This is certainly witnessed by close to one thousand (1,000) of pages in the Proposed Rule. The apparent goal for CMS as well as providers is to make the transition from the current Medicare reimbursement system to one that is progressively based on quality and value, not simply fee-for-service.

2 2 It is virtually impossible for community oncology practices to absorb all of the detail, and implications in the Proposed Rule, while dealing with the numerous other challenges CMS has thrown at them in just the last few months, notably including the Part B Model referenced previously. We very highly recommend that CMS publish a refined interim final rule before moving to a final rule. We understand that CMS has a statutory requirement to publish a final rule in the November time frame; however, CMS has been flexible in the past in meeting congressional deadlines. We believe that CMS should prioritize “getting it right” over hurried deadlines. Indeed, we believe that CMS wants practices to be well-versed and prepared to make a successful transition to MIPS or an APM, as the case may be.

In all of the oncology payment reform pilots COA has analyzed to date, the keys to success in enhancing quality/value

and increasing efficiency are the following:

 Understanding the quality and value criteria the practice will be measured by;

 Putting in place the clinical and operational procedures that are designed to enhance quality/value and increase efficiency;

 Receiving timely and actionable information/data on the measurements; and  Making adjustments at the practice and/or provider levels to improve performance on quality/value and efficiency.

Given these essential keys to successful payment reform, we believe more time is necessary for practices to understand and prepare for MIPS and APMs, as the case may be. We, therefore, request a more stepped approach to ensure the shared goal is met of successfully transitioning to the intent of MACRA. There is simply too much riding on this— starting with the health of seniors covered by Medicare—to not get it right.

To do this, we ask that CMS use a refined interim final rule to further streamline and simplify both MIPS and APM structure, implementation, and measurements based on comments received to date and CMS’ additional work on these programs. A refined interim final rule, with a focus on simplification, would allow providers both more time to understand the MIPS and APM programs, as well as, prepare for them by putting in place the appropriate clinical and operational procedures to ensure success. While we appreciate the undertaking of CMS to implement MACRA into actual clinical practice, the Proposed Rule as it stands now is far too complex and complicated. We believe that streamlining the processes is key to the successful transition to an evolved Medicare payment system.

We believe that the guiding principle in the evolution of the payment system should be on minimizing the time physicians are involved in processes and on maximizing the time spent with patients on their care and treatment.

Quality and value should be rewarded, but the payment system must be simplified and woven into clinical processes, not overly burdensome and separate from patient care. Let physicians be physicians; not data entry clerks and administrators.

We are very concerned that the sheer volume and detail in the Proposed Rule and a rush to measurement starting on January 1, 2017, will result in providers “throwing up their arms” in frustration and simply begrudgingly being resigned to the measurement, and not actively preparing for and embracing where our health care system is headed.

We are especially concerned about small and medium-size practices adequately preparing for at least MIPS, even with CMS resources and guidance in helping them, given the pressures they already face. It is vital for this endeavor to be thoughtful, not a rush to implementation.

Recommendation 2: Use 2017 as the year for practices to understand, operationalize, commit, and implement clinical and operational procedures to making them successful under MIPS and the APM arms, as the case may be.

Initiate formal measurement on January 1, 2018, so that practices can adequately prepare for being measured, not retroactively.

We understand that CMS is working with a deadline of MIPS and the AMP arms going live in 2019. However, with the final rule scheduled towards the end of 2016, it will be virtually impossible for practices to be ready by January 1,

2017. We therefore strongly recommend that 2017 be used to prepare for MIPS and APMs and that 2018 be used as 3 3 the first year to calculate future payment adjustments. Please give practices the opportunity to engage proactively in this, not to sit back and begrudgingly accept whatever adjustments are made.

In keeping with our keys to success previously shared, we also recommend a shorter reporting period in the first year of the program to ninety (90) days. We have found in oncology payment reform that more frequent feedback is essential to changing processes that engender great quality and value of the care delivered.

Recommendation 3: We request that CMS include all of the OCM practices initially in the APM arm, as well as practices participating in OMH models. CMS needs to broaden its definition of financial “risk” to be more realistic and encompassing.

CMS outlines some considerations for qualification as an APM, which we consider to be too self-limiting. An

advanced APM must be one of the following:

 CMMI model;

 Medicare Shared Savings ACO;

 Demonstration under Health Care Quality Demonstration Program; or  Other demonstration required by federal law.

There have been a number of programs, both federal and private, which have exhibited significant savings, coupled with quality and value, utilizing EHR technology, quality measures, and risk factors. Community oncology practices participated in the CMMI demonstration project known as the COME HOME project, led by COA Board member Barbara McAneny, MD at New Mexico Cancer Center. That project yielded significant savings along with excellent quality care, utilizing measures approved by CMMI. Yet, that model has been excluded from consideration as an advanced APM.

Further, a number of community oncology practices have been, and continue to, participate in OMH demonstrations with major payers, such as Aetna and PriorityHealth. An incredible amount of time, energy, and money have been spent making these models successful. We feel it is very shortsighted for CMS to exclude OMH-based programs from consideration when they have already demonstrated success in meeting the metrics outlined in the Proposed Rule.

The concept of financial “risk” in these models needs to be broadened to not only include the back-end risk to the medical practice in terms of “paying back” when quality and/or savings targets are not met. Community oncology practices transitioning to an OMH model of practice incur significant financial burden on staff and resources, such as transiting to a 24/7 operating environment. The “risk” is that the financial investment—at a time when CMS has ratcheted down reimbursement—to an OMH configuration will not produce results increasing reimbursement in order to keep the practice financially viable.

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