LAUSR

Arecent survey of state Medicaid programs by the Senate Finance Committee revealed that of 68 million Medicaid enrollees in 44 states, nearly 700,000 are positive for the hepatitis C virus (HCV). The advent of new direct-acting antivirals (DAAs) has not just given these patients treatment without the devastating side effects of interferon; it has given them the promise of a cure. However, as 88% of states have established and now implemented restrictive prior authorization policies regarding new DAAs in clear violation of federal mandate, the promise of a cure is one that the Medicaid system is not fulfilling. As such, it has been left to doctors and advocates to stand up for the rights of these individuals in a fight not unlike that faced in the early years of the human immunodeficiency virus crisis. We have seen that change is possible. What we are urging is that greater change will come from providers’ willingness to serve as advocates. It is important to note that coverage for outpatient prescription drugs within a Medicaid plan is not a requirement by federal or state mandate. Rather, it is a decision left entirely to each state. However, despite being optional, every state has chosen to participate in the Medicaid Drug Rebate Program and is therefore de facto bound and accountable to the regulations set forth in the Social Security Act, title XIX. Hence, while prior authorization requirements are neither forbidden nor uncommon in state Medicaid plans, they should comply with federal regulations. As it stands now, with more than 40 states having not only instituted restrictive prior authorization policies but also continuing those violations in direct defiance of Medicaid’s November 2015 Medicaid Drug Rebate Program Notice, the joint Medicaid system shows a grave weakness in that it does very little to recognize and reprimand the blatant noncompliance of state partners. This perspectives piece addresses the common question of both doctors and advocates: What can I do right now to make a change? It so happens that we are not alone, not without cause, and not without a roadmap. There are at least 10 states to which we can look for guidance in achieving greater access and the elimination of restrictions (see Table 1). Recent successes toward improved access to DAAs include advocacy-driven demand letters, four class action lawsuits, related investigations initiated by the state attorney general toward private insurers, challenges to state prison systems, and recommendations by drug utilization review boards. The arguments used in the above successes, some of which we review below, include one or more of three basic arguments: failure to provide care that is medically necessary, failure to provide care with reasonable promptness, and failure to provide comparable care.