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:
- Reminder that states are required to cover these medications under the terms of the Medicaid Act.
Under Section 1927(b) of the Medicaid Act, states must cover all drugs of manufacturers that have entered into rebate agreements for all "medically accepted indications." All the manufacturers of the new HCV treatments have done so. In the notice, CMS reminds states that they are only allowed to exclude drugs of these manufacturers when the excluded drug does not have a significant clinically meaningful therapeutic advantage over other treatments and there is a public, written explanation of the basis for the exclusion. Although the discussion of Section 1927(b) is written to specifically address HCV concerns, this language is applicable to other conditions that have experienced unjustifiable limitations on access to critical medications.
- Notice that budgetary impact is not a sufficient justification to exclude HCV medications.
CMS also noted that, although the financial concerns of state Medicaid programs are legitimate, the launch of multiple new HCV medications has brought the cost of the new treatments down significantly. As such, states are encouraged to negotiate for pricing arrangements rather than to forgo coverage of these medications. To support negotiation efforts, CMS has sent letters to the relevant pharmaceutical manufacturers asking them to provide information regarding any value-based purchasing arrangements they offer.
- Notice that limitations on access must not unreasonably restrict coverage of effective treatments.
CMS stated that restrictions limiting access to treatment to individuals with a fibrosis score of F3 or F4, requiring sobriety periods and limiting the ability of providers to prescribe to a narrow range of provider types are unreasonable restrictions on access to HCV medications. CMS is directing states to examine their drug benefits to ensure that limitations do not unreasonably restrict coverage of these medications. CMS also noted that states should use the unified HCV Treatment Guidelines of top medical societies to guide their coverage policies.
- Reminder that Medicaid MCOs must match FFS plans in access to treatments.
CMS also noted that MCOs tend to be more restrictive in coverage for HCV medications than their corresponding Medicaid FFS. In the notice, CMS reminded states that the services provided by Medicaid MCOs cannot be less in the amount, duration and scope of what beneficiaries receive under Medicaid FFS. CMS urges states to monitor their MCOs to make sure that access to HCV medications in managed care is comparable to FFS or to consider setting up a "carve out" for HCV drugs to provide access through the FFS system even for MCO enrollees.
- Assurance that CMS will monitor state compliance.
CMS promised that it will monitor state compliance with applicable regulatory filings, statutes and regulations to make sure that access to HCV medications are maintained in a manner consistent with the requirements of the Medicaid Act and the guidance provided. This demonstrates a commitment on the part of CMS to improve access to HCV medications.
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.