November 11, 2015
A new notice from the Centers for Medicare and Medicaid Services (CMS), released on Nov. 5, directly addresses some of the most problematic and restrictive utilization management techniques limiting access to effective, high-cost treatments for hepatitis C, such as Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir). The Medicaid Drug Rebate Program Notice, titled "Assuring Medicaid Beneficiaries Access to Hepatitis C (HCV) Drugs," may be one of the most important sub-regulatory guidance pieces on access to medical care to be issued by CMS since their powerful guidance on access to HIV treatment in the 1990s.
The notice is important for the HIV community not only because of high rates of HIV and HCV co infection in the United States, but also because it strengthens protections around access to high-cost medications, such as those for HIV treatment.
The notice makes it clear that the federal government is aware of unjustifiable barriers in state Medicaid programs and Medicaid Managed Care Organizations (MCOs) to access to HCV drugs, including requirements that individuals have advanced liver disease (fibrosis), periods of abstention from substance use or referrals from specialized clinicians. None of the criteria cited by CMS as egregious have any medical basis, and all of these criteria have long been contested by advocates, medical experts and patients.
The notice has already had an impact on access to medical care -- within 24 hours of the release of the notice, states and MCOs were removing restrictions to HCV drugs. For example, an MCO in New Mexico reportedly dropped the fibrosis and substance use restrictions to treatment in response to this notice.
This notice can be a powerful tool in the hands of advocates, who can now remind their state Medicaid programs that they have a clearly articulated responsibility to provide access to HCV medications (as well as other high-cost medications) and that such access can only be restricted by reasonable and medically justifiable criteria. This applies both to fee-for-service (FFS) plans and managed care. In addition, states should be reminded that cost concerns should be addressed through price negotiations with pharmaceutical manufacturers instead of unjustifiable restrictions. In an age in which access to medications is increasingly constrained by unjustifiable criteria, utilization management, prior authorization and other restrictions, this notice is an important tool to ensure that individuals maintain access to the medications they need.
Here are some key points included in the CMS notice on hepatitis C treatment access:
Carmel Shachar, J.D., M.P.H., is a clinical instructor at law at Harvard Law School's Center for Health Law and Policy Innovation and previously was an associate in Ropes & Gray LLC's health care group. Shachar focuses on issues around state and federal implementation of health care reform as well as data privacy and security.
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