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New litigation forces states to stop restricting HCV treatments


States had restricted Medicaid recipients’ access to drugs, but new court rulings are changing that practice.

New litigation is forcing states to stop restricting hepatitis C virus (HCV) treatment for Medicaid recipients.

In June, a federal judge in Washington State ruled that the state Medicaid authority cannot place undue limitations on access to HCV drugs for patients, and the Delaware Division of Medicaid and Medical Assistance changed the policy of rationing HCV drugs to no longer restrict treatment only to those with significant liver damage or cirrhosis.

In November 2015, the Centers for Medicaid & Medicare Services (CMS) issued a guidance letter informing states that they needed to remove restrictions to access to treatment for HCV. Many states, citing the high cost of direct-acting antiviral (DAA) drugs to treat HCV, had restricted Medicaid recipients’ access to these drugs only to patients whose liver has already sustained serious damage.

“Many states saw the CMS guidance letter as advisement and choose to ignore it. Now there has been litigation to remove restrictions and improve coverage. This may trickle down to the private sector and allow coverage to HCV patients before they suffer irreparable liver damage,” Sonia Canzater, an associate with the O'Neill Institute for National and Global Health Law at Georgetown University, told Medical Economics.

Several states, including Pennsylvania and Florida, are quietly reviewing and thinking about issuing changes to Medicaid policies, she said.


These landmark steps by states are “essential,” she said. “It is past due that all of the state Medicaid authorities revisit their treatment policies and remove any barriers to treatment for HCV patients. If they continue to resist, they are now on notice that costly and likely unsuccessful litigation is inevitably in their future.”

Restricting coverage to the sickest HCV patients “seems counter-intuitive to efficient health care provision and budgeting. The new drugs have a high cost, but they provide curative treatment for HCV infections, and can prevent the adverse health effects and associated treatment costs caused by a prolonged chronic HCV infection, such as cirrhosis, liver cancer or liver failure,” said Canzate, noting that early treatment of HCV infections also improves patients’ overall quality of life and long-term potential workforce productivity.

“The up-front costs to health care insurers may be steep, but the long-term return on investment is the cost savings of a lifetime of expensive health care for a chronically infected HCV patient,” she said. “Political opinion is changing the conversation away from costs and towards providing a long-term investment.”

Canzater continued: “If we treat HCV infections early, we are able to clear the virus before patients sustain permanent effects to the liver. It makes more sense to invest in preventive health on the front end. There is a lot of talk about how expensive DAAs are. In reality, between discounts and insurance coverage, the average patient does not pay the sticker price for these drugs. We need to look at the human factor, not just the cost.”

She implores physicians to play a role “in advocating for insurers to remove restrictions on HCV treatment and to help change the conversation about what it costs in the long-term.”


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