Breaking Down Barriers to Hep C Treatment

This article was originally written by Jennifer Tzeses and published in HealthCentral on July 20, 2021. 

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A SNEAKY, SILENT killer, hepatitis C is a viral infection that often shows no signs or symptoms. And because most people don’t know they have it, the virus can linger in your system for decades—until complications crop up, potentially causing cirrhosis (scarring) or liver cancer. According to the Centers for Disease Control and Prevention, it’s the deadliest infectious disease in the U.S.—and it’s widespread. The Food and Drug Administration reports it’s the most common chronic blood-borne infection in the United States with roughly 3 to 4 million new infections occurring each year.

For reasons not quite understood, about 30% of people who have hep C clear the infection through their own immune system, according to the World Health Organization. For the remaining 70%, treatment can mean the difference between life and death. The (really) good news in all of this is hep C is 98% curable, thanks to a class of medications known as direct-acting antivirals (DAAs) and often in as little as eight to 12 weeks. (That’s true even if you contracted hepatitis C 30 years ago and are just seeking treatment now.) Keep in mind, though, that there is no vaccine for hep C. So if you get treated, then keep doing whatever caused you to contract the disease the first time, you can still get it again.

While DDAs are basically a magic wand for hep C sufferers, those on Medicaid have historically faced a host of unfair barriers to treatment access. “When the drugs came out in 2014, there was a giant price tag, and so payers like Medicaid created rationing schemes for fear they would blow a hole in their budgets if they treated everyone,” says Phil Waters, J.D., staff attorney, Center for Health Law and Policy Innovation at Harvard Law School in Boston. In turn, Medicaid began to limit access to coverage by implementing three main restrictions: liver disease progression, sobriety requirements, and prescriber restrictions, Waters says.

Liver Disease Progression

Thanks to this restriction, patients are required to reach a certain stage of fibrosis before being eligible for treatment in the Medicaid program. “Fibrosis is the amount of damage done to your liver measured on a scale of zero to four with zero meaning no scarring and four essentially being liver failure,” Waters says. “Medicaid programs made a cutoff for fibrosis levels to limit treatment. In Arkansas for example, you don’t get access to treatment unless you’re at three or above, which is almost a cirrhotic level,” he says. “It’s basically telling people with a deadly infectious disease that they have to wait until they get sicker to be treated.”

Substance Use and Sobriety Requirements

Patients with a history of substance or alcohol abuse need to show they are free of drugs or alcohol before they are approved for treatment under Medicaid. “Not treating people who are active users is not only wrong from a moral standpoint, but from a public health perspective, since these are the individuals who are most likely to spread Hep C to others,” Waters says. “It’s hard to see this as anything other than a cost containment measure or, really, reinforcing stigma against drug users for being honest.”

Prescriber Restrictions

Only certain specialists are allowed to prescribe DDAs. Which, in theory, sounds feasible, however, “in a state like West Virginia where there’s one hepatologist in the entire state, it starts to make sense why there’s a bottleneck for an entire cohort of patients that need this treatment,” Waters says. And along with limited prescribers, prior authorization protocols required by certain plans end up delaying treatment even further. “The provider has to fill out extensive paperwork certifying they are in fact a gastroenterologist or hepatologist and show that a patient has been clean and sober. This is in addition to lab reports,” Waters says.

Consequences of Barriers to Care

“These restrictions delay and restrict access to care for tens of thousands of Americans, not only allowing their health to deteriorate, but also undermining public health efforts to eliminate viral hepatitis by 2030,” says Adrienne Simmons, PharmD, director of programs for the National Viral Hepatitis Roundtable (NVHR), an advocacy organization in Washington, D.C. “Every new HCV infection represents a failure to cure the index case, and a generation struggling to survive the overdose crisis will face long-term health consequences—cirrhosis, cancer, transplant, and death from HCV if Medicaid policies are not revised to facilitate access to treatment now.”

Thankfully, there are groups advocating for change—namely, Hepatitis C: State of Medicaid Access, a joint taskforce between CHLPI and NVHR. Through a national report and state-by-state report cards, the group provides an evaluation of treatment access in each state’s Medicaid program. “The report cards track prior authorization requirements for HCV treatment-based liver damage, sobriety, and prescriber restrictions,” Simmons says. “This data guides our administrative and legislative advocacy efforts and arms local advocates with the information they need to push for the removal of restrictions in their state.”

The changes can’t come soon enough for patients and hep C advocates, who are still battling for access to care. “Providers are reticent to treat people who are actively using drugs because they heard from their infectious disease colleagues in the interferon [drug] days about how difficult treatment was to manage,” Waters says. “And so, they just get scared and say, ‘Nope, not going to do it. This is too difficult.’ I think that kind of thinking permeates the medical community and the people who make payment decisions.” The biggest reason states who have removed restrictions for fibrosis are keeping sobriety restrictions in place, he says, is because of fears about reinfection or treatment adherence. “It’s a political capital problem,” Waters says.

Progress Makes Perfect

Sobriety restrictions remain the most pressing and widespread barrier to accessing hepatitis C treatment. “Many states have reduced restrictions regarding required periods of abstinence yet screening and counseling restrictions continue to amplify stigma surrounding alcohol and drug use and create additional hurdles for patients seeking treatment,” says Simmons. Questions about substance use and adherence on prior authorization forms only end up creating the opportunity for providers to discriminate against patients based on non-evidence-based assumptions about adherence, she adds. This often discourages people who use drugs from seeking testing and treatment.

Still, progress is happening. Since 2017, 32 states have either eliminated or reduced their fibrosis restrictions, 21 have loosened their sobriety restrictions, and 25 have scaled back their prescriber restrictions for Medicaid coverage, Simmons says. There are now also seven states that, in addition to removing all restrictions, have removed prior authorization for treatment entirely: these include Washington, Louisiana, New York, California, Indiana, Wisconsin, and most recently, Michigan. Says Simmons, “In these states, the barriers to getting treatment through Medicaid have been paved over with a road to treatment.”