State Medicaid Programs Ease Illegal Restrictions on Hepatitis C Medications, but More Progress Needed

When Greenwald first set out to survey Medicaid restrictions in 2014, he ran into a fundamental problem. Seventeen states did not make their criteria public, meaning that Greenwald and other advocates had little way of knowing which policies were in place except by word of mouth from patients. By 2016, only seven states did not have publicly available policies, Greenwald explained during his presentation. The numbers have improved: 73% of states had available information in 2014, compared with 82% in 2016. Despite the progress, Greenwald and Clary called on all state Medicaid directors to immediately release hepatitis C treatment access criteria.

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When the new-era hepatitis C medications started being approved by the FDA in 2013, their extraordinary price tags, upwards of $95,000 for a course of treatment, caused extreme anxiety among cash-strapped state Medicaid programs, as well as the insurance industry at large. Payers responded by essentially triaging patients: denying coverage to those whose disease had not progressed to an advanced stage of fibrosis or cirrhosis, called F3 and F4. In 2014, nearly all states with known plans required F3 or F4 liver disease.

Yet, this restriction is illegal, a fact that was spelled out in a harshly worded letter from the federal Centers for Medicaid and Medicare Services on November 5, 2015. Since 2014, 16 states have alleviated or even eliminated their restrictions, Clary said, but a vast majority of states retain some sort of liver disease requirements. Only five states -- Wyoming, Florida, New York, Connecticut and Massachusetts -- currently have no restrictions and are therefore complying with federal rules, Clary explained.

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Multiple studies have demonstrated that, with training, primary care providers are just as capable as liver specialists at treating hepatitis C successfully. Yet, when direct-acting antiviral medicines first became widely available, many state Medicaid programs (and private insurance companies) adopted a policy that only certified hepatologists or gastroenterologists were allowed to write prescriptions. This limited access to patients, especially in states with too few specialists to treat thousands of infected patients.

By 2016, provider restrictions had eased, although to a lesser extent compared with liver damage restrictions. Eight states have eased prescriber limitations, while two states -- Connecticut and Massachusetts -- have eliminated the requirement altogether, Clary explained. Louisiana and South Dakota, on the other hand, have tightened prescriber limitations, so clearly more progress is needed, Clary said.

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Many states require patients to pass sobriety tests to qualify for hepatitis C medication, even though treatment guidelines clearly support starting treatment in drug and alcohol users. On this front, there has been some progress, Greenwald said, but not nearly as much as in the area of liver disease (fibrosis) restrictions. By comparison, 36% of states have reduced their fee-for-service fibrosis restrictions, but only 18% of states have reduced their fee-for-service sobriety restrictions, Greenwald said.

"The other really disturbing news is that, at the same time, 16% of states went toward more restrictions rather than fewer restrictions," Greenwald told the audience. For example, in 2014, some states asked patients with a positive drug test to undergo screening and counseling. Later, those states moved toward a harsher restriction, requiring abstinence for several months. Moreover, sobriety rules vary widely among various health plans offered under the same state Medicaid program, which makes it confusing for providers and patients to known when sobriety will be required.

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Managed care organizations (MCOs) and fee-for-service programs are two ways of delivering health care, and MCOs play an increasingly important role in managing Medicaid for beneficiaries with hepatitis C. The data presented at The Liver Meeting offered the first-ever assessment of MCO coverage of HCV treatment access. It's an important distinction, Greenwald explained, because MCOs are not allowed to enact policies that are more restrictive than the corresponding fee-for-service policies, yet many MCOs do so in violation of the law.

Among states with both MCOs and fee-for-service programs, eight states have MCOs that are more restrictive than the corresponding fee-for-service program. For example, Clary explained, "New York moved from F3 to no fibrosis restrictions in its fee-for-service program, but it's very important to note that the MCOs in New York still restrict access to F3, which is an absolute violation of federal Medicaid law that prohibits MCOs from having stricter access than fee-for-service programs."

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The report presented at the Liver Meeting offered a preliminary peek at the full data set that will be presented next year.

"In January we will have an updated final draft, and we will also have state report cards, ranking and information about every single state's HCV treatment and access restrictions," Greenwald told the audience. Still, it is clear from these preliminary findings that state Medicaid policies have improved somewhat, but far too many states still restrict access to direct-acting antivirals, Greenwald said. The situation is likely to improve, Greenwald and Clary agreed.

"There is consensus emerging that restrictions will be improved, either voluntarily or through litigation," Clary said. Yet, in 2016, "too many states are violating the law and threatening the health of their Medicaid beneficiaries with hepatitis C," Clary added.

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