Monday, September 28, 2009

Consilience in Legal Protections for Health IP

Gregg Bloche, a Yale-educated doctor and lawyer, recently published a new article on “The Emergent Logic of Health Law”. He describes health law as an emergent system as follows:

Competing values and stakeholders, not grand designs, drive health law’s evolution. Reform-minded actors therefore should become opportunists. They should look for potential evolutionary pathways that launch from present-day institutional arrangements and incentives. And they should pursue legal and policy interventions that push our health system along these pathways, powered by stakeholders’ and legal decisionmakers’ interacting responses. The key here is to craft interventions that are “nonlinear” (in emergent systems argot)—interventions that achieve large, long-term impact through minimally disruptive short-term change.

In other words, the strategic reformer must focus efforts on areas of consilience between the status quo and efforts for change. Bloche’s systems-based explanation provides a compelling rationale, for example, to President Obama’s deference to Congressional leadership. Congressional impramateur makes sense from an emergent systems perspective because Congress is, for better or worse, the best proxy for the many interest groups concerned with health care reform. From an emergent systems perspective, then, deference to Congress lets those interest groups define terms as much as possible while retaining political capital to  intervene at critical junctures.

Bloche also has some micro-level suggestions for reformers who aren't Presidents or members of Congress. In this entry I’ll describe a particularly unique suggestion from Bloche on legal changes that could reform the system from the ground up, and also dish up some criticism where Bloche gets important facts wrong.

One of Bloche’s ideas for holding down costs in a politically savvy way is to find ways to disincent expensive procedures that don’t bring much benefit. Rather than denying end of life care, which despite its utilitarian merits strikes many as unpalatable, he proposes a strategy that will reduce the ongoing proliferation of “half way cures”. He defines “half way cures” as “marvels of engineering, electronics, and materials science, and of modest, often minimal medical benefit”. They are very expensive but minimally useful. To hold the cost down, then, Bloche proposes limiting the intellectual property protections available for these kinds of drugs, devices, and processes. He acknowledges that administrative challenges abound in trying to define “halfway cures”, but he does propose a useful starting point to be a determination of whether the treatment is based on a comprehensive grasp of the biological system. Penicillin, for example, was developed after understanding how to break down bacteria cell walls. His examples of treatments where our understanding of the biological system is less complete includes “drug-coated stents designed to keep atherosclerotic arteries open, high-technology life support, and last-ditch radiation and chemotherapy regimens meant mainly to sustain hope”. He also proposes using Medicare payments to make primary physician consultation and coordination time relatively better compensated than specialty “half way cures”. In time, this would likely result in decreased supply of the high cost minimal benefit technologies.

One emergent area of reform opportunities overlooked by Bloche is high deductible health plans. He states that “[Consumers have been reluctant to] appoint themselves as limit setters by signing up for lower-cost coverage that kicks in only after they and their families spend thousands of dollars on care out-of-pocket.” On the contrary, high deductible health plans have been the largest growth segment in the insurance marketplace. Moreover, the financial institutions that act as custodians to the health savings accounts (HSAs) coupled to high deductible health plans have been among the strongest investors in transparency and quality of care tools. The financial institutions seek to demonstrate value to the consumer by helping the consumer to make smart healthcare decisions. Banks have outperformed insurance companies on measures of trust (at least until recently), security, and availability. Online banking systems (see, e.g., Canopy Financial's suite as implemented by Sovereign Bank) now serve as a point of aggregation for all manner of health decision and quality tools for consumers. The current bills devote significant verbiage (see, e.g., provisions on "navigators") to setting up mechanisms for this kind of distribution of information and support to consumers. The Bacchus bill explicitly references HSA figures to set standards for coverage, perhaps taking a page from Bloche's "emergent systems" strategy suggestions. High deductible health plans coupled with HSAs may yet continue to form a point of consilience between the status quo and efforts for change.