The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / CMS Notice Urges Access to Hepatitis C Cures for Medicaid Patients

CMS Notice Urges Access to Hepatitis C Cures for Medicaid Patients

by Amanda Conschafter, blog editor

The Centers for Medicare and Medicaid Services has a message for state Medicaid programs: coverage policies cannot block hepatitis C patients’ access to “effective, clinically appropriate and medically necessary treatments.” The statement speaks to new, direct-acting antiviral treatments with a high cure rate for sufferers of the chronic disease. Many health plans and state Medicaid systems have imposed rationing techniques and labyrinthine prior authorization processes to limit the number of patients taking the costly medications. This trend led to widespread complaints from patients and discriminations accusations.

[WATCH: Improving Patient Access to Hepatitis C Cures ]

Lawful Access

State Medicaid programs with prescription drug benefits must, by law, provide coverage for medications whose manufacturers have agreed to a Medicaid rebate program. However, as CMS’ November 5 notice explains, the agency is “concerned” that some states, contrary to the law, are imposing requirements that “may unreasonably restrict access to these drugs.” The notice calls out specifically practices that restrict access to patients until they reach stage 3 or 4 liver fibrosis. It also pinpoints systems that require patients to abstain from alcohol or drug use for a period of time prior to accessing the medications.

“While states have the discretion to establish certain limitations on the coverage of these drugs,” the notice explains, “such practices must be consistent with [applicable law].” Limitations typically apply to drugs prescribed for uses outside their Food and Drug Administration indication or those that do not demonstrate a clinically meaningful benefit in comparison to other drugs on the plan’s formulary.

[SEE : The Path to a Hepatitis C Cure]

CMS also pointed out American Association for the Study of Liver Diseases guidelines on testing, managing, and treating hepatitis C. The notice encourages states to “consider implementing programs that provide [hepatitis C] patients…with supportive care that will enhance their adherence to regimens, thereby increasing the success rates.”

Cost Considerations

CMS acknowledges the challenge that hepatitis C cures’ cost pose for state Medicaid systems, explaining that “The agency shares these concerns.” Agency officials have written a letter to the manufacturers of hepatitis C cures requesting information about “value-base purchasing arrangements.” But the notice’s authors also note the role of market competition in driving down prices for hepatitis C cures. “The recent launch of multiple [hepatitis C curative drugs]…is creating competition…that may result in downward pressure on the prices of these drugs,” the notice explains.

Next Steps

State Medicaid systems now face the task of incorporating CMS’ input. As states work to ensure that their access requirements comply with applicable law, CMS plans to “monitor the policies and conditions states impose…to ensure compliance…and access to effective, clinically appropriate, and medically necessary treatments for beneficiaries.”

But though the CMS notice provides a needed nudge for state Medicaid systems, patients with private insurance or health plans purchased through a federal or state exchange may continue to face hurdles in accessing hepatitis C treatment. The form and timing of recourse for these patients remains to be seen.

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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