Center Comments on Innovation Center New Direction

November 20, 2017

Via Electronic Submission

CMMI_NewDirection@cms.hhs.gov

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

RE: Request for Information on Innovation Center New Direction

Dear Administrator Verma:

The Center for Medicare Advocacy (Center) is pleased to provide the Centers for Medicare & Medicaid Services (CMS) with comments on the Center for Medicare and Medicaid Innovation (CMMI) Request for Information on Innovation Center New Direction.  The Center, founded in 1986, is a national, non-partisan law organization that works to ensure fair access to Medicare and quality healthcare. At the Center, we provide education and advocacy on behalf of older people and people with disabilities to help secure fair access to necessary health care. We draw upon our direct experience with thousands of individuals to help educate policy makers about how their decisions affect the lives of real people. Additionally, we provide legal representation to ensure that people receive the health care benefits for which they are eligible, and for the quality health care they need.

Our comments primarily address guiding principles, both those articulated in the RFI and additional principles that we believe are important as CMMI moves forward with any new demonstration. We also address the question of appropriate models for CMMI support. The comments are informed by our work with Medicare beneficiaries.

1. Guiding Principles

Beneficiary Choice – Clarity in Communications

The first and second guiding principles in the RFI address choice and tools needed to exercise choice. We support beneficiary empowerment so they can make the best choices possible. To make that happen, all beneficiary communication about a demonstration, both at the start and throughout, should be in consumer-tested simple language, and accessible to individuals with disabilities and to those with limited proficiency in English.

Beneficiary Choice – Tools and Assistance

Among the guiding principles set out in the RFI is giving beneficiaries “the tools and information they need to make decisions that work best for them.” To exercise informed choice, beneficiaries need easy-to-use and accessible tools that allow them to compare options. They also need to have free personalized assistance available to help them understand their options and their chosen coverage, something that is especially important for the many older adults and persons with disabilities who have difficulties using online resources.

We note that while beneficiary empowerment based upon useable, accessible information about health care and coverage is itself a laudable goal, the availability of such information does not necessarily lead to individuals making the most optimal choices on their own behalf, or even engaging in active decision-making when confronted with multiple options.[1] Choice and transparency must not replace robust consumer protections that ensure that all beneficiaries, not just savvy consumers, are guaranteed quality care, coverage and outcomes.

Beneficiary Choice – Voluntary participation

The RFI stresses the importance of provider choice and incentives, favoring voluntary demonstrations. We urge that, more importantly, beneficiary participation in any demonstration that impacts their receipt of services should also always be voluntary. Demonstrations are, by their very nature, trials of untested systems meant to address deficiencies. Testing those systems should be a choice available to beneficiaries and not mandatory.

Beneficiaries with multiple chronic conditions have often spent months or years developing provider networks that work well for them. They should always be given the option to keep their providers and not be required to disrupt their care to participate in a demonstration. 

Patient-Centered Care

Care that is patient centered is not simply established by patients “taking ownership over their health”—it requires that patients are given the tools and supports to be active participants in both their own health care decisions and the processes and systems that impact their health, including CMMI demonstration models. Patient-centered care takes into consideration the patient’s life situation, including family and caregiver circumstances, as well as the patient's values and preferences, age, and home environment when making health care and treatment recommendations. It also places a high priority on preventive care, care coordination, and care management, including support for self-management, to help patients become and stay healthy.

To be truly patient-centered, care models must address the social determinants of health. There is mounting evidence that addressing social and economic factors, such as poverty, education, housing and food security, and racial discrimination, is critical to improving health outcomes. Social factors account for nearly a third of deaths in the US every year and factors such as stress, low-incomes, and low education levels are directly associated with poorer health outcomes or premature death.[2]

We believe that the federal government can do more to promote approaches to health that address the social barriers preventing individuals and communities from achieving health and well-being. Specifically, we ask that CMMI:

• Develop new demonstration models for Medicaid that could fund social services such as housing and nutrition support that have been demonstrated to improve health. These demonstrations should be rigorously evaluated to assess their impacts on health outcomes and costs, and to identify best practices.
• Revise ACO demonstration models to add a provision for a percentage of shared savings to be invested in community health programs that address disparities and the needs of the community.
• Focus on promoting partnerships between Medicaid programs and community-based organizations (CBOs) and social service providers.
• Include incentives and structures in new payment and delivery models that encourage providers to screen for social service needs and refer to appropriate services.
• Promote data collection and standards around social determinants of health.

Patient-centered care must prioritize models that address the needs of people with complex health conditions, as individuals with complex health conditions have very different needs from the general population. Thus, new models of payment and delivery that may work for some patients will not work for these populations. For example, efforts to increase price transparency are often irrelevant or counterproductive for patients with rare or complex needs who have limited choices in terms of providers or treatment options, or who most benefit from care that is well coordinated and grounded in longitudinal relationships with care providers. Patients whose biometric markers are impacted by underlying genetic diseases are not well served by models that pay providers based on improving those particular markers. Additionally, long-term care needs are a major priority for these populations. Often the long-term goal for many patients with complex conditions or disabilities is not about curing a disease but about ensuring the person can live comfortable, productive lives in their home and community.

One difficulty of implementing payment models that are tied to positive health outcomes, is that such models can disincentive providers from caring for more complex patients who may be more likely to have poor health outcome measures. Payment models should not penalize providers who care for low-income, high needs, and complex patients. It is important that any payment models supported by CMMI recognize the greater degree of difficulty in caring for patients with complex needs, including social and behavioral health needs, as well as their physical health needs. It is important to note that certain medical conditions are degenerative by nature, and it is unreasonable to expect an individual to improve. For example, individuals with Parkinson’s, Multiple Sclerosis or Alzheimer’s will not expect to improve. However, they can maintain their condition or slow deterioration of their condition through targeted therapies. CMMI must develop models that take this reality into account and not limit incentives to improved health outcomes. Models should reflect that for degenerative conditions, maintaining level of function, or slowing deterioration of the condition, is a successful and positive health outcome.

We ask that CMMI both prioritize models that serve these populations’ needs, as well as consider how broader models might impact these populations differently. Many of the suggestions we have already laid out can help achieve this goal, for example ensuring there are strong consumer engagement mechanisms and promoting models of care that are based on patient driven health goals. In addition to these asks, we ask that CMMI:

• Work closely with the Medicare-Medicaid Coordination Office to continue testing and evaluating innovative models of care delivery for patients who are eligible for both Medicaid and Medicare (dual eligible).This should include testing new models, as well as continuing models that are already underway in order to evaluate and learn from these models.
• Promote increased access to home and community based services through waivers and the continuation of programs such as Money Follows the Person and the Balancing Incentive Program.
• Expand community-based models of care for individuals with complex needs, including Programs of All-Inclusive Care for the Elderly (this includes innovative PACE-like pilot programs that also serve the under 55 population) and the Independence at Home Demonstration.
• Continue to prioritize care delivery models focused on care coordination and case management.

Transparent Model Design and Evaluation

We strongly support transparent model design, including full transparency and broad stakeholder participation in all stages of planning and implementation. Rigorous evaluations also are necessary to determine what is working well in a demonstration and what is not. In addition to looking at health outcomes and financial results, evaluations should include a beneficiary experience element. To be most useful, evaluation data should be made public as soon as possible and disaggregated so that impact on particular subpopulations can be assessed.

Consumer Protections and Robust Oversight

In addition to the guiding principles discussed in the RFI, one principle that should always be of prime importance is inclusion of consumer protections, along with oversight so that those protections are effective. All demonstrations should ensure that beneficiaries are not harmed by changes. Strong consumer protections must be in place, including effective appeals and grievance processes, adequate and genuinely available provider networks, and strong quality and safety standards. To be effective, these protections must be accompanied by adequate oversight and enforcement. CMS has an overarching obligation to beneficiaries to provide robust oversight of providers and plans, an obligation that is even more important when new models are being tried and unexpected issues arise that could harm beneficiaries.

We urge the creation of robust feedback loops to monitor beneficiaries’ experiences throughout any demonstration, and to respond in real time to potential problems. It is essential that CMS establish a mechanism designed to monitor, and receive stakeholder input on, beneficiary access.  The full monitoring and oversight plans should be made publicly available prior to carrying out the model. We also recommend that CMS develop and release a public plan for corrective action, should the agency observe unintended consequences that limit beneficiary access to needed care.

Ombuds

Having an ombuds program that can assist beneficiaries in navigating a demonstration and that also can identify and address systemic issues has proved effective in the past. We urge that an ombuds function, adequately funded, be part of every demonstration.

Systems Testing and Readiness Reviews

The start of any demonstration is the time when beneficiary access to care can be most at risk, and the issues often arise from systems errors: failure of data transfers to work correctly among participating entities, coding errors, unanticipated impact of demonstration changes on other systems or programs, etc. We strongly urge rigorous and extensive systems testing before the start of any demonstration. Robust readiness review procedures for participating providers and plans, states (if participating) and CMS itself also need to be developed for each demonstration. Readiness review should address not just computer systems but personnel commitments to the demonstrations, provider understanding of the demonstration and all other elements.

Continuity of care

A related start-up concern is continuity of care. Even with notices, many beneficiaries are caught unaware when elements of their care delivery change.  Having care continuity protections in place is essential so beneficiary health is not endangered. For protections to work, providers must be well educated on their mechanics. Further, the protections must be easy for both providers and beneficiaries to navigate.

2. Potential Models

Consumer Directed Care & Market-Based Innovation Models

Demonstrations that erode the universality of Medicare coverage by segmenting beneficiaries into those who can afford to pay additional amounts to providers and those who cannot do not advance the goals of the Medicare statute.

We have concerns about models that explore easing private physician contracting rules in Medicare. Proposals include allowing physicians to contract more selectively, and allowing physicians to bill patients on top of the Medicare rate. The Center is concerned that these proposals would undermine the financial protections that have been in place in Medicare for many years, and could increase out-of-pocket spending for beneficiaries, sometimes with unexpected and unaffordable charges. These changes undermine the universality of the Medicare program, which is centered around predictable and affordable costs for all beneficiaries.

Demonstrations that impose additional cost burden on struggling Medicaid beneficiaries or shrink their access to needed services do not advance the purposes of the Medicaid statute. We strongly urge CMMI not to pursue such models. Advocates are keen about instead working with CMMI to increase consumer-directed care and empower beneficiaries within models that provide positive incentives and that do not threaten bedrock principles in Medicare and Medicaid.

We also ask that CMMI not test or promote models of care that create other, non-financial barriers to care access. This includes work requirements, drug testing, and plan designs that limit access to certain benefits or that cut benefits categorized as “non-essential”, but that many individuals require for good health, like adult dental benefits. There is little evidence suggesting that these methods lower cost or alter participant behaviors in the manner intended. In fact, these models often lead to increased administrative costs and burdens on state Medicaid programs.

Medicare Advantage (MA) Innovation Models  

While we recognize CMS’ stated intention to maintain benefit flexibility and efficiency throughout the Medicare Advantage (MA) program, we stress that CMS’ focus should not be on rolling back regulations, reducing oversight or minimizing plan sponsor burdens.[3]  Rather, we urge CMS to focus squarely on ensuring Part C enrollees (and the broader Medicare population) have access to and receive timely, quality health care.  CMS needs to ensure that MA plans provide what taxpayers are paying for; ultimately, both beneficiaries and taxpayer dollars must be safeguarded.

We urge CMS to proceed very cautiously when seeking to loosen current rules and restrictions on plans in the name of innovation or easing administrative burden.  Based upon our experience assisting MA enrollees, and the research showing people who are sicker tend to disproportionately disenroll from MA plans, we do not support waiving existing anti-discrimination rules that prevent MA plans from denying, limiting or conditioning coverage or provision of benefits based on any health status-related factors.[4]  Correspondingly, rules should not be changed to allow MA plans to design covered benefits in such a way that is likely to discourage enrollment by certain individuals. 

We remain concerned that too much flexibility risks allowing some MA plans to devise discriminatory plan designs, intentionally or otherwise.  Any flexibility given to MA plans must be subject to transparent, well-developed criteria established by CMS in consultation with other stakeholders, including clinicians, researchers and consumer advocates. When assessing whether to give plans any flexibility in benefit design or cost-sharing, we commend CMS for the approach taken in the MA Value Based Insurance Design (VBID) model, in which consumer protections remained paramount.[5] 

Any lessons learned and potential successes from demonstrations or trials relating to flexibility in MA plan benefits and structure should, to the extent possible, be applicable to all Medicare beneficiaries, regardless of how they choose to access their benefits. Lowering or eliminating cost-sharing in traditional Medicare, as well as offering some of the other positive incentives outlined in the MA-VBID proposal, could also benefit the majority of beneficiaries who choose to remain in Traditional Medicare.

Should the MA-VBID model and others like it result in positive health outcomes for MA enrollees, we hope that CMS will both make lessons learned from this model publically available and, as appropriate, integrate promising practices into the Traditional Medicare program and beyond. Thus, we encourage CMS to evaluate this demonstration program—through design, implementation, and monitoring—in light of how positive results might be expanded beyond the MA program.

In addition, while the RFI does not specifically articulate a plan to develop a premium support (voucher) demonstration, we are concerned that, given that one of the primary goals of premium support would be to reduce federal spending, beneficiaries would feel the brunt of any reductions in coverage and increases in out-of-pocket costs.  There are various ways a premium support program could be developed, and, as with many policy proposals, details matter, including who would be affected by a demonstration, or a fully-scaled in reform to the Medicare program.  Even grandfathering in current Medicare beneficiaries from a new voucher system could result in harm to them.  As noted in a recent Health Affairs blog,  “if a new premium support system for Medicare separates younger from older seniors, it runs the risk of rapidly rising premiums and health care costs for today’s seniors, possibly culminating in a ‘death spiral’ for the current Medicare program.”[6]  We urge CMS to refrain from testing any premium support models.

Support for the Dual Eligible Financial Alignment Demonstration

We ask that CMMI continue to support the Medicare-Medicaid financial alignment initiative (FAI), which is mid-stream in implementation. There has been a huge investment by stakeholders, plans, states, and MMCO in the design and implementation of the FAI, and much is being learned about what works and what does not, best practices, alignment of incentives and many other elements involved in the care of dual eligibles, who are disproportionately the highest need, highest cost beneficiaries for both the Medicare and Medicaid programs.

Several hundred thousand beneficiaries are currently enrolled in FAI state demonstrations. Shutting the demonstrations down just as the implementation phase is bearing fruit would cause significant disruption in their care. Further, the demonstrations in the participating states differ in significant aspects, providing a wealth of information and on-going learning as plans and states identify implementation challenges and develop responses. Much value would be lost if, after all the groundwork that has been laid, the demonstrations are not allowed to play out at this critical stage. Continuing to support the FAI will provide time for a thorough evaluation of the impact of the different state models on beneficiary outcomes and program costs.

Oral Health Demonstrations

We ask that CMMI test and promote models of care that focus on the integration of mental, behavioral, and oral health services. For far too long, oral health has been seen as separate from physical health and not given adequate attention in the development of new payment and delivery models. However, addressing a person’s oral health needs is essential in ensuring improved health outcomes and is a necessary component of patient centered care. We ask that CMMI place an emphasis on developing models that focus on treating the whole person and improving integration of oral health services into primary care.

Oral health integration requires recognizing that oral health is an integral part of overall health and wellness. It involves primary care and other medical providers taking responsibility for oral health and specific strategies for incorporating dental health care services into the broader health care system. We ask CMMI to consider the following oral health demonstrations:

• Traditional Medicare Program Demonstration:  CMS or CMMI should conduct a geographically-based demonstration project to study the impact of providing a dental benefit in traditional Medicare. The demonstration would evaluate health outcomes of such coverage on a broad array of Medicare patients. This would allow a comparison of the impact on costs and health care compared with the control group of the large majority of Medicare beneficiaries who are in traditional Medicare and do not have such coverage.
• Expansion of MCBS-based Research:  Given the availability of detailed coverage and expenditure data in the Medicare Current Beneficiary Survey, CMS should expand its research linking those data with other MCBS information and beneficiary claims data to provide better estimates of the prevalence of medical conditions for which outcomes might be improved with access to better dental care.
• Disparities Research:  Given the high prevalence among minority beneficiaries of chronic illnesses for which untreated dental disease is an additional risk factor, and the additional problems of access to dental care in minority communities, CMS should analyze existing data sources to identify specific communities in which improved access to medically necessary dental care might have an especially large effect.
• Joint Registry Development with FDA on Immunosuppressive Drugs:  Given the growing importance of immunosuppressive drugs in the treatment of cancer, severe rheumatoid arthritis, and other conditions especially prevalent among Medicare beneficiaries, and the high risks for patients with untreated dental disease in taking such medication, CMS should work with the FDA and drug manufacturers on creating registries of clinical and health services data for patients prescribed such medications.
• Coverage Determinations:  CMS should convene a work group to immediately explore options for expanding Medicare coverage of medically necessary oral health services under existing legal authorities, including through a National Coverage Determination (NCD).  The workgroup could also draw on the research currently underway to develop more systematic clinically-based definitions of “medically necessary oral health care.” The work group could begin by considering the life-threatening dangers faced by beneficiaries requiring resolution of serious dental issues prior to or after solid organ and stem cell transplants, head and neck cancer treatment, and other major medical procedures. 

We ask that CMMI focus on promoting the following strategies for oral health integration:

• Integrated referral systems, where dentists screen for health needs and refer to a physician (and vice versa)
• Shared electronic health records (EHR) systems that allow both dental and medical providers to easily view each other’s entries. A recent study showed that access to integrated information technology is one of the leading barriers to oral health integration
• Co-located services, which include locating dental services in the same building with medical care and also involve integrating care delivery. Especially promising are new models where a dental hygienist, dentist, or dental therapist works in a primary care office or clinic or a nurse practitioner or physician’s assistant works in a dental office
• Redesigning medical and dental education curricula to include comprehensive education for all providers around overall health that includes oral health
• Including incentives in new payment and delivery models that encourage integration of oral and physical health

Prescription Drug Pricing Demonstrations

We believe that CMMI should revisit the pricing model for Part B medications considered in 2016. The Center for Medicare Advocacy submitted comments regarding this demonstration, as we supported the aim of reducing costs and increasing beneficiary access to effective prescription drugs.[7] We remain committed to these goals. We urge CMS to test strategies that lower or eliminate beneficiary cost-sharing on prescription drugs. That proposal also incorporated many essential consumer protections, particularly for value-based pricing strategies new to the Medicare program. We urge CMMI to look to that model as new value based pricing models for prescriptions drugs are developed.

3. Conclusion

We appreciate the opportunity to submit these comments. For additional information, please contact David Lipschutz, Senior Policy Attorney, dlipschutz@medicareadvocacy.org, and Kata Kertesz, Policy Attorney, kkertesz@medicareadvocacy.org, both at 202-293-5760.