Health Care Innovation, But 'First, Do No Harm.'

Health Care Innovation, But 'First, Do No Harm.'
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Let's be honest. When it comes to health care policy, it’s impossible to get it right. 

The goal for U.S. health care policy is fairly straightforward: a system which provides affordable and accessible health care to Americans across the country.

The problem is that achieving this goal is enormously difficult. The dynamics of U.S. health care are in constant flux. The science of medical advances, demographic shifts, societal and sector-specific economics are never stable and diseases constantly emerge and retreat. Yet, the goal remains. 

With the above in mind, new approaches for organizing, delivering and paying for health care are required. The incentives of old payment models block progress. Developing new delivery systems to assure better and more efficient coordination of care must be tested even though it will be resisted. Involving patients and their families in maintaining health and managing care seems promising, but how do we effectively engage them? 

If the goal of quality, affordable health care is to be achieved, every aspect of the system will need to be regularly considered, redesigned, reinvented, disrupted and tested. The need for innovation could not be greater.

Fortunately, the Centers for Medicare and Medicaid Services (CMS) has reiterated its commitment to value-based programs. Through its Center for Medicare and Medicaid Innovation (CMMI), new models which reduce the rate of spending growth and enhance the quality of care provided to Medicare and Medicaid beneficiaries are being tested. 

Today, more than 130 million Americans rely on Medicare and Medicaid for their health care needs. As those programs continue to grow, value-based innovations which deliver high-quality, cost-effective solutions are more essential than ever.

CMS recently issued a Request for Information (RFI) on how to redirect its innovation programs with a focus on new principles: choice and competition in the market, provider choice and incentives, patient-centered care, benefit design and price transparency, transparent model design and evaluation and small-scale testing. These are each reasonable adjustments to CMMI's prior direction and will likely deliver valuable lessons for programmatic reforms.

As CMS evaluates how CMMI should approach its mission, it is critical to establish safeguards for the program that will ensure accountability and transparency in testing new models and reforms. 

First off, CMS should ensure that the program operates as it was intended and establish models that include limits on population, scope and duration of the tests. In recent years, CMMI failed to include such safeguards and, instead, proposed programs that applied to nearly every Medicare or Medicaid beneficiary in the country. Rather than perform a test, these “models” would have resulted in wholesale changes to the programs. Among CMS' new guiding principles for CMMI is small-scale testing. This should avoid the overly broad tests that have been previously tried.

Similarly, CMS' RFI sets out principles of transparency in benefit design and price as well as model design. CMS is to be congratulated for recognizing the need for openness. But it should also take the next step: allowing beneficiaries an opportunity to decline to participate in certain models. For many patients, changes to established treatment plans can have adverse, even devastating consequences. Providing exceptions and opt-outs would allow patients to avoid inappropriate changes to their care. In that same vein, some beneficiaries could face unintended consequences from poorly developed models. To ensure that innovations to be tested are appropriately modeled and risk assessed, input from patients and medical professionals is critical.

As with all government programs, oversight and accountability are paramount. CMMI has broad authority.  Judicial and administrative review is barred for many of CMMI's decisions, including the selection of sites or participants to test models; the elements, parameters, scope and duration of models to be tested; and the modification of the design of a model to be tested. In effect, CMMI can conduct, select and test models with unilateral discretion. There should be appropriate checks and balances to assure that permanent changes to Medicare and Medicaid are appropriately considered by Congress.

Innovation in our health care system offers the promise of improving quality and economic efficiency. CMMI's search for innovative payment and delivery models is laudable and will, hopefully, result in systemic improvements. But, CMMI's program of model selection, testing and implementation must also be subject to oversight and beneficiary protections.

As the forces that shape our health care system change, so too the structures of health care delivery and economics must evolve. Conceptualizing, designing and testing new payment and delivery models within a "first, do no harm" framework is our best hope to advance to the ultimate goal. 

Let's get on with the innovations we need.

Bruce Merlin Fried is a partner at Dentons and the former director of Center for Health Plans and Providers at the Health Care Financing Administration (HCFA; now the Center for Medicare and Medicaid Services).

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