he Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued Friday by a federal judge in Seattle.
The ruling came in response to a lawsuit filed by state residents who claim the drugs are “medically necessary,” and that the decision by the Washington State Health Care Authority to provide coverage to only the sickest patients had caused them harm.
In a strongly worded, 12-page opinion, United States District Court Judge John Coughenour agreed with their argument. He wrote that the facts “clearly favor” their contention that state policy violates federal law. In his view, the evidence “establishes that there is a consensus among medical experts and providers that the life-saving [drugs] are medically necessary” for all hepatitis C patients.
The treatments boast very high cure rates but also are very costly, ranging in price from $54,600 to $94,500, depending upon doses and regimen, although this is before any rebates or discounts are applied. The hepatitis C treatments include Sovaldi and Harvoni, which are sold by Gilead Sciences, as well as medicines sold by Merck and AbbVie.
One attorney who represents the state residents hailed the opinion.
“This is the first time a federal court has declared that widespread restrictions across a state Medicaid program is illegal for hepatitis C medicines,” said Kevin Costello, litigation director at the Center for Health Law and Policy Innovation at Harvard Law School. “It’s also important because this can be used to persuade other state officials to lift restrictions.”
He indicated that still more lawsuits against state Medicaid programs are planned, but would not discuss specifics.
We should note that the Obama administration last fall wrote state Medicaid programs that they may be violating federal law by restricting access to hepatitis C medicines. Placing restrictions may be “contrary to the statutory requirements” of a federal law that requires state Medicaid programs to pay for all medically necessary treatments, Center for Medicare & Medicaid Services officials wrote in their notice to the state programs.
A spokeswoman for the Washington State Health Care Authority said the court opinion is being reviewed.
The opinion is only the latest instance in which a public or private insurer has been forced to reconsider its coverage policies toward hepatitis C medicines, which helped trigger a wave of controversy over the cost of prescription drugs.
Last month, seven commercial insurers reached an agreement with the New York attorney general to remove barriers to coverage of pricey hepatitis C medicines. The health plans had to eliminate restrictions that require their members to have an advanced stage of the disease, such as liver scarring, before treatment would be considered medically necessary. And various commercial insurers in Washington state and California recently eased coverage restrictions in response to lawsuits filed by consumers.
Meanwhile, lawsuits are pending against the Indiana Family and Social Services Administration and the Massachusetts prison system. And the Massachusetts Attorney General has threatened to file a lawsuit against Gilead if it did not lower prices. That standoff has not yet been resolved.