Colorado’s Medicaid agency was hit with a federal lawsuit last week claiming it illegally restricted treatments for thousands of low-income hepatitis C sufferers.

The American Civil Liberties Union filed the class-action lawsuit in federal district court despite a pivot earlier this month by the health agency to expand access to new life-saving drugs. The new drug rules, which the ACLU says do not go far enough, take effect Saturday.

The lawsuit was filed on behalf of a low-income Denver resident, Robert Cunningham, who was diagnosed with the communicable disease more than a decade ago but has recently been denied access to direct-acting antivirals, a new class of drugs used to treat hepatitis C.

Some of the new therapies can cost $40,000 or more for a 12-week prescription. The new drugs, however, have fewer side effects than the medications used to treat hepatitis C prior to 2013, the lawsuit said.

Other states, including Illinois, in recent months have moved to expand the number of hepatitis C patients who have access to the new drugs. In May, a federal district court ordered the state of Washington’s Medicaid agency to make most enrollees with hepatitis C eligible to receive the new prescription drugs.

If left untreated, hepatitis C can cause serious liver damage and even death.

It is most common among baby boomers and those who inject drugs, and kills more people in the United States than any other infectious disease, according to the Centers for Disease Control and Prevention. 

For years, the Colorado Medicaid program, now called Health First Colorado, required those with hepatitis C to have advanced liver scarring before they could receive the new drug therapies, according to the ACLU’s lawsuit. The Colorado program used to require patients to have a liver fibrosis level of “F3” or higher to qualify for the new drugs, but that score has now been relaxed to “F2.”

“The department estimates that the 70 percent of our Medicaid population that has hepatitis C has a fibrosis score of F2 or above,” said Marc Williams, a spokesman for the Colorado Department of Health Care Policy and Financing.

Williams said this doesn’t mean that everyone with a score of F2 or higher — some 10,000 Coloradans — would be eligible for the new drug treatments, which have a cure rate of more than 90 percent. The updated policy also lists other requirements, such as enrollment in a substance abuse treatment program for at least one month if the person has a history of drug or alcohol abuse.

“While someone with an F2 score would likely satisfy the other criteria, there may be some who don’t, so we’re careful to avoid blanket statements,” Williams said.

ACLU officials said that low-income Colorado residents are being denied the hepatitis C treatments despite a federal law requiring state Medicaid agencies to foot the bill for such medically necessary drug therapies.

“We are challenging a policy that forces Coloradans who cannot afford private insurance to live with the serious negative health effects of hepatitis C and to wait for a cure, possibly for years, until they have suffered measurable and potentially irreversible liver damage,” Mark Silverstein, the ACLU of Colorado legal director, said in a prepared statement.

The new drug therapies, which have been approved by the Food and Drug Administration, are covered by the Veterans Administration, Medicare and the vast majority of private health insurers in the state, the ACLU lawsuit said.

“We believe that there is no medical justification for the restrictions we are challenging,” Silverstein said in an email to AMI Newswire. “We believe the agency’s rationale must be based on cost, which we contend is not a legitimate or legal justification.”

ACLU officials said the Colorado agency’s policy shift to allow patients with an “F2” fibrosis score to receive the new drugs does not go far enough.

“The latest policy change is a half-step that falls short of what the law requires, which is full access to medically necessary treatment for all patients with hepatitis C,” Sara Neel, an ACLU staff attorney, said in a prepared statement.

The ACLU lawsuit also contends that, in the long run, expanding the use of the new drugs will be cost-effective. Curing the disease earlier will preclude paying for ongoing treatments that would have been needed had the disease been allowed to progress and cause additional liver damage, the lawsuit said.

Silverstein said no court hearing has been set and that the Colorado health agency has 20 days from the time of being served to respond.