After filing a class action case in U. S. District Court for the District of Kansas on behalf of two Medicaid recipients, Jamie Harper and Jessica Owens, Shook attorneys and the American Civil Liberties Union of Kansas (ACLU) have negotiated a settlement agreement with the State of Kansas that requires the state to treat every Medicaid recipient suffering from hepatitis C (HCV) with curative, lifesaving treatment of direct-acting antiviral (DAA) drug therapy, irrespective of the stage of liver fibrosis, sobriety from alcohol or illicit drug use.
Before the settlement, KanCare, the state’s privatized Medicaid program, refused to approve DAA drugs for Medicaid enrollees suffering from HCV unless they had advanced liver disease measured by a Metavir score of F3 or higher, and/or who had not been sober from alcohol or illicit drug use for at least three months.
HCV is a communicable virus that attacks the liver and can lead to chronic infection, muscle pain, chronic fatigue, depression, diabetes, cardiovascular disease, cirrhosis, liver cancer and death. HCV is the leading reason for liver transplants in the U.S. In the past, multidrug regimens produced at best a 70 percent cure rate but with significant adverse side effects. But in 2013, new single-drug antiviral drugs that have a 90 percent or higher cure rate with fewer side effects became available.
Under the Federal Medicaid Act, participating states that choose to offer prescription drug coverage are required to cover drugs manufactured by companies that have entered into rebate agreements with the U.S. Department of Health and Human Services for “medically accepted indications.” All of the single-drug manufacturers have done so, and the treatments are FDA-approved for HCV.
Kansas, like many other states that did not choose to expand Medicaid coverage under the Affordable Care Act, deliberately withheld DAA drug therapy on the basis of cost. The state chose to treat only Medicaid enrollees with advanced disease to avoid more costly liver transplants, leaving those with lower F scores (1 and 2) to suffer the effects of the disease and possibly spread it while awaiting treatment. In the process, Kansas and other states ignored medical standards of care universally recognized by liver and infectious disease specialists. Shook and the Kansas ACLU were part of a 13-state effort to obtain compliance with medically necessary treatment for Medicaid enrollees.
Under the settlement, KanCare enrollees will no longer be denied treatment based on their F score or because of a history of alcohol or illicit drug use. However, those who test positive for illicit intravenous drug use within three months of their request for antiviral treatment have been excluded from the class, as Kansas officials insisted on continuing a moral but not medical judgment to withhold treatment for this small group of Medicaid enrollees.
The ACLU told KCUR in a recent interview that the state has assured the plaintiffs that there is sufficient funding in place to cover treatments for the additional patients.
Shook Partner Stan Sexton represented the plaintiffs with co-counsel Lauren Bonds of the ACLU. Partners Scott Kaiser, Andy Carpenter, Russell Shankland and Associates Brent Dwerlkotte and Britta Stamps, with paralegal Trish Carlson and legal administrative assistant Tina Cady, also were on the Shook legal team. The Shook team received invaluable pro bono assistance from Dr. Jody Olson, a hepatologist at the University of Kansas Medical Center, and Dr. Blair Thedinger, a primary physician at KC CARE Health Center, both of whom treat many Medicaid enrollees with HCV and were distraught that their patients were being denied medically necessary treatment.
Shook lawyers and the ACLU are presently engaged in negotiations with the Kansas Department of Corrections to obtain similar treatment for prison inmates suffering from HCV who are likewise being denied DAA drug therapy.
The case is Harper v. Andersen, No. 18-4008 (D. Kan., November 20, 2018).