CMS instituted protections for antiretrovirals in 2006 when Medicare Part D was first implemented that have been critical to our HIV patients. As one of six “classes of clinical concern” plans have been required to cover all of the drugs within the antiretroviral drug class, and in recognition of the health risks for HIV patients posed by delayed access to antiretrovirals, plans have been barred from applying any utilization management techniques, such as prior authorization or step therapy, to this drug class.  We are greatly concerned by the possibility that our patients’ access to antiretrovirals could be subject to the delays that they experience in accessing their nonantiretroviral medications, delays caused by the complex and lengthy prior authorization requirements and other utilization management techniques employed by Medicare Part D plan sponsors to control costs.

Implementation of beneficiary-level controls under Medicare Part D is troubling in part because a majority of Medicare Part D plans do not have a financial incentive to support appropriate management of HIV therapy since they are not responsible for costs incurred by other parts of the health care system if a beneficiary’s antiretroviral therapy is poorly managed. We urge you to proceed with caution in implementing beneficiary-level controls for antiretrovirals under Medicare Part D and to consider the recommendations offered below.