June 30, 2015 — A study published in the Annals of Internal Medicine has found that most state Medicaid programs could be violating federal law by restricting access to expensive drugs that can cure hepatitis C, such as Harvoni.

Federal law require Medicaid programs to cover all FDA-approved drugs and not discriminate in drug coverage.

According to federal law, a state “may not arbitrarily deny or reduce the amount, duration, or scope of a required service… to an otherwise eligible beneficiary solely because of the diagnosis, type of illness, or condition.”

Researchers looked at Medicaid policies for people with hepatitis C and found that 42 states restricted payments for Sovaldi (sofosbuvir). About 74% of those programs limited treatment to individuals with advanced fibrosis or cirrhosis. Many private health insurers impose similar restrictions.

The most common restrictions included:

  • The level of fibrosis (scarring of the liver)
  • Substance abuse and abstinence from alcohol and drug use
  • Provider limitations on prescribing physicians

Left untreated, hepatitis C can cause cirrhosis, liver failure, liver cancer, and death. The longer a patient goes without treatment, the higher the risk of spreading the highly-contagious blood-borne virus to other people — especially if they use injection drugs.

When Sovaldi was approved last year, it revolutionized the treatment of hepatitis C. Finally, doctors had a drug with at least a 90% cure-rate and very few side effects. Unfortunately, with a price-tag nearing $100,000 for a standard 12-week treatment, Sovaldi has been out of reach for all but the richest or sickest people with hepatitis C.

Dr. Lynn E. Taylor, lead author of the study, said:

“Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access. The denial of treatment by most states violates the spirit of the law. In our analysis, we found that most states with known sofosbuvir Medicaid reimbursement requirements impose undue restrictions on eligible recipients.”