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Gary Puckrein: The Democratization of Health Care: The Vote Was for Quality Care

The Department of Health and Human Services is in the process of finalizing the federal standards that will guide states in defining the minimum essential health benefits that all healthcare insurance plans participating in the state-based health insurance exchanges will be required to provide. The comment period on the proposed rules began on Nov. 26 and ended on Dec. 26 -- the day after Christmas. Yes. A disturbingly inconvenient deadline following a relatively short comment period for such a critical rule (myriad touted comments to the Dec. 16, 2011 bulletin notwithstanding). Public comment time frames that do a disservice to the transparency and public engagement that the administration claims to value are barriers to that which it purports to enable -- public comment.

Before HHS issues final essential health benefits regulations that will encourage drug formularies, the Secretary must consider the essential health needs of our heterogeneous American general population. Creating administrative structures that support access to quality health care for all of us demands a range of therapeutic and pharmaceutical options that cannot be served by anachronistic approaches to cost and utilization management.

During the run-up to the recent election, President Obama's supporters constantly stressed the need to raise taxes on the one-percent to rescue us from the fiscal cliff. But a wedge issue that stirred more passion in that election was whether to sustain or repeal the Affordable Health Care Act. Obamacare is now settled law and public policy -- tested in the courts; codified by the vote of the American people.

The ACA moves our health care system a step closer to providing health insurance to all Americans. An essential step because our system of health care consigns those without health insurance to intermittent and rescue care. This unfortunate norm has resulted in patterned outcomes that we accept as intractable health status disparities and absolve ourselves of any responsibility. While expanding insurance coverage begins the process of eliminating those patterns, let us not confuse this expansion with increased access to quality health care. In the latter regard, our work has only just begun.

Nature is grudgingly responding to our efforts to use medical interventions to extend life, but Americans classified as minorities, soon to constitute the majority, are still more likely to suffer and prematurely succumb to a wide range of debilitating diseases -- cancer, diabetes, chronic heart failure and the like. Diseases that are amenable to currently available therapies and pharmaceuticals. Diseases that can be managed -- sometimes cured.

People can, and often do, respond differently to medication and therapeutic regimens. Benefit designs must allow for this heterogeneity. It is essential for patients, and the providers who treat us all, to have access to the full spectrum of FDA-approved medications without administrative or financial hurdles that are not firmly rooted in quality care. These hurdles generally take the form of formulary management tools: preferred tiers, prior authorization, fail-first policies, dispensing limits, and specialty tiers.

Created in an era when we accepted structured health care disparities, prescription drug formularies have been a standard feature of private and social (mandated public) insurance. So standard, in fact, that they are being grandfathered into the essential health benefits rules that Secretary Sebelius is in the process of promulgating as part of the regulatory underpinnings that support implementation of ACA.

HHS is moving in the right direction. It has moved away from earlier thoughts about "one drug per class" which would have permitted plans to offer a formulary with a single drug in a therapeutic class without regard for medical need, quality care or diversity. The current proposal -- the greater of one drug in every category and class; or the same number of drugs in each category and class as the EHB-benchmark plan -- is a marginal improvement, but still woefully inadequate.

Let's be clear -- formularies are inherently discriminatory. They ignore heterogeneity; they deny access to medicine to those least able to pay; and most importantly, they violate the pledge that brought people from their homes to have their commitment tested by the gauntlet of long lines at polling places.

While some will argue the use of formularies in essential health benefits is implicit in the law, it is only that - implicit. The non-discrimination provision in ACA is explicit. The law reads: "...benefits must not be designed in ways that discriminate based on age, disability, or expected length of life, but must consider the health care needs of diverse segments of the population". There is no such clear instruction to create formularies.

Patient responses differ. America's physicians must be empowered to prescribe the therapies that best meet the needs of their patients -- without the hindrance of financial or administratively structured delays. Rules that focus on the number of drugs that can be prescribed, rather than the quality of the drugs, and the preferences of health plans rather than the physician, threaten the health of patients, and cost all of us more money in the end.

America's goal must be to provide quality health care to all citizens while keeping costs under control. To do so, we must create a consumer-oriented health care system. When health plans respond to the needs and preferences of all consumers, disparities can be erased and real waste reduced. Americans voted to extend access to quality health care. We did not vote for structured inequalities.