Medicaid Skimps on Hepatitis C Treatment in Many States

Expert Critique

FROM THE ASCO Reading Room

Michelle Long Assistant Professor of Medicine, Department of Medicine, Section of Gastroenterology Boston University School of Medicine

Though direct-acting antiviral (DAA) therapy for hepatitis C has revolutionized treatment, access to effective treatments is a major concern. In some states, Medicaid programs may cover treatment; however, restrictions on who can receive treatment are put in place, which limits access. For example, some state Medicaid programs will cover treatment only for those with advanced fibrosis or those treated by hepatologists, and nearly half of state Medicaid programs require a minimum of 6 months of abstinence from drug or alcohol use. Given the high cost of DAA treatment, Medicaid coverage restrictions limit access to therapy since it is not feasible to undergo treatment without insurance coverage. Prior research supports the use of DAA therapy for all patients with chronic hepatitis C with a reasonable life expectancy, regardless of the degree of liver fibrosis. Additionally, limitations to the practitioners who can prescribe DAA therapy are particularly restrictive for communities when specialist care is limited and prior evidence suggests that those treated by general practitioners have a similar response to treatment and cure rate. Finally, prior studies show that patients with hepatitis C and substance abuse, including active drug users, can be successfully treated with DAA therapy. The restrictions on coverage imposed by state Medicaid programs are not evidence-based, and certain states are facing lawsuits for imposing restrictions to coverage.

Full Critique

A growing number of state Medicaid programs broadly cover hepatitis C treatment, but many still impose restrictions that are not supported by medical evidence, according to a recent report.

"Hepatitis C: The State of Medicaid Access," issued by the National Viral Hepatitis Roundtable (NVHR) and the Center for Health Law and Policy Innovation (CHLPI) at Harvard Law School, evaluated hepatitis C treatment policies in all 50 states, the District of Columbia, and Puerto Rico.

The report shows that 12 states cover treatment only for people with advanced liver fibrosis, 20 states require at least 6 months of abstinence from drug or alcohol use, and nine require treatment to be prescribed by a liver disease specialist, NVHR executive director Ryan Clary reported at the American Association for the Study of Liver Diseases (AASLD) annual Liver Meeting in October.

"Hepatitis C kills more Americans each year than all other infectious diseases combined, yet more than half of U.S. Medicaid programs continue to impose discriminatory and medically unfounded restrictions on hepatitis C cures," Clary told MedPage Today. "Giving Medicaid recipients broad access to a cure is critical if we are really serious about eliminating this country's deadliest blood-borne disease."

The advent of direct-acting antiviral agents (DAAs) for hepatitis C is regarded as one of the major achievements of modern medicine. The latest interferon-free regimens cure more than 95% of people with all genotypes of hepatitis C virus (HCV) in 8 to 12 weeks.

However, a large proportion of people infected with HCV are not benefiting from these advances, either because they have not been diagnosed or because they cannot access the new treatments. A recent analysis found that only 55% of the nearly three million people living with hepatitis C in the United States are aware of their status.

In the interferon era, many patients and providers decided against hepatitis C treatment because it lasted 6 months to a year, often caused difficult side effects, and cured the disease only about half the time. But the new therapies are so effective and so well tolerated that there is little reason to forego treatment -- except for the high cost of the drugs and limitations on public or private insurance coverage.

Medicaid coverage has increased since interferon-free DAAs became available in 2014, with several states dropping restrictions over the past 3 years in accordance with growing evidence that they are not medically justified. Transparency has improved dramatically, and all states now make their criteria public.

But the report shows that Medicaid fee-for-service (FFS) programs in 12 states still require patients to progress to advanced or stage F3 fibrosis before they qualify for treatment, while 18 more require moderate or stage F2 liver damage. Medicaid managed care organizations (MCOs) vary widely in their coverage, including several that "carve out" hepatitis C treatment entirely.

Based on the latest medical evidence, the HCV guidelines developed by AASLD and the Infectious Diseases Society of America (IDSA) recommend treatment for all patients with chronic HCV infection, regardless of liver disease stage, with the exception of those who have a short life expectancy for other reasons.

The access report shows that Medicaid FFS programs in two states (Louisiana and North Dakota) require a full year of sobriety or abstinence before a patient qualifies for treatment, while 18 states require 6 months, five require 3 months, and two require a single month.

These sobriety limitations are not supported by scientific evidence, with research showing that people on opioid substitution therapy and active drug users can successfully complete hepatitis C treatment and achieve a cure.

"The restrictions on treating active drug users make a public health approach toward eradicating hepatitis C impossible, fostering an environment where hepatitis C continues to spread in our communities," Diana Sylvestre, MD, executive director of the OASIS clinic in Oakland, CA, told MedPage Today.

Medicaid FFS programs in nine states only cover hepatitis C treatment provided by specialists such as hepatologists. In addition, 28 require that treatment must be done in consultation with a specialist.

These restrictions are also not supported by research. Studies show that primary care physicians and nurse practitioners can successfully provide hepatitis C treatment, with cure rates matching those of specialists.

"Provider restrictions compound the problem, as access to subspecialty care can be nonexistent in healthcare systems that care for medically marginalized persons," Sylvestre said. "Treating hepatitis C is easier and less costly and more effective than treating HIV, diabetes, hypertension, and so many other things, and thus treatment restrictions are very hard to rationalize without invoking prejudice and stigma as their root cause."

The report reveals that the status of Medicaid access to hepatitis C treatment is not closely correlated with geographic region or "red" versus "blue" political leanings. Alaska, Connecticut, Massachusetts, Nevada, and Washington merited an "A" rating, while Arkansas, Louisiana, Montana, Oregon, and South Dakota warranted an "F." Just over half the states got a grade of "D" or worse.

In some states lawsuits have been filed to remove restrictions on hepatitis C treatment. In November 2015, the Centers for Medicare & Medicaid Services (CMS) issued a bulletin advising states that limitations on coverage "should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections." CMS also urged drug manufacturers to do their part to ensure access and affordability.

But advocates argue that states are still not doing enough to make sure that everyone who could benefit from hepatitis C treatment has access to it -- especially in light of falling drug prices and the recent approval of AbbVie's Mavyret (glecaprevir/pibrentasvir), which substantially undercuts other regimens on the market.

"As the findings of our report illustrate, many state Medicaid programs are violating federal law by imposing discriminatory restrictions that keep people from getting lifesaving medical care and treatment," CHLPI director and Harvard Law professor Robert Greenwald told MedPage Today.

"Restrictions to treatment based on disease severity and sobriety have no basis in the medically accepted standard of care and serve only to cut cost and increase stigma surrounding hepatitis C. While the cost of treatment certainly presented challenges initially, now states are hiding behind costs and ignoring the fact that the cost has actually decreased 75% over the past 3 years and will decrease even further as new treatment options enter into the marketplace."