For two years Vickie Goldstein filed appeals and wrote letters trying to get Florida’s Medicaid program to pay for a drug with the potential to cure her of the viral infection that was slowly destroying her liver.
For two years she got the same answer: You have to get sicker first.
“I talked to a couple of attorneys who specialized in insurance law, and they all said to me, ‘We can’t make any money suing the government,’ so they didn’t want any part of it,” said Goldstein, who at 57 had been living with hepatitis C for more than a decade.
Finally, in December 2015, her Internet search hit upon Florida Legal Services Inc. staff attorney Miriam Harmatz, a health law expert whose work is supported by The Florida Bar Foundation.
“I stumbled onto Miriam. She was the only one I saw who represented poor people and not hospitals and doctors,” said Goldstein, a resident of Delray Beach.
As it turned out, Harmatz would not be alone in representing Goldstein. She quickly brought in Vicki Tucci Krusel, managing attorney of the Coverage to Care Legal Initiative of the Legal Aid Society of Palm Beach County, as well as Abbi Coursolle of the National Health Law Program (NHeLP).
“They were the most amazing group of women that I have ever met,” Goldstein said. “I mean they just went right into action mode.”
At the time, Goldstein had already lost her appeals through her Medicaid managed care company and was about a month away from a fair hearing with the Florida Division of Administrative Hearings. She handed over to her legal team reams of documentation, along with research she’d done to support her case.
“She’s such a strong and brave woman, but at the same time she was very physically broken, emotionally broken from this fight in trying to really save her own life,” Krusel said.
Goldstein’s coverage denials were based on a policy of the Florida Agency for Health Care Administration (AHCA) and its contracted Medicaid managed care companies. The policy required that a patient’s liver fibrosis, or scarring, be at least a three on a four-point scale, with stage four liver disease being so severe that patients often need a liver transplant. Goldstein was not yet stage three, but her health was compromised. She had no appetite, weighed about 100 pounds, and her brain was foggy all the time.
Dr. Michael Fried, director of hepatology at the University of North Carolina at Chapel Hill, said delaying therapy until a patient has progressed to advanced fibrosis places that person at risk for liver cancer and other complications of cirrhosis.
“The best management is to treat patients in early stages of disease, prior to the development of scarring,” Fried said.
Goldstein’s attorneys knew they needed to get results quickly for Goldstein, but Goldstein wanted to do more.
“We wanted Vickie to get her medicine as soon as possible, because she was quite ill, but she was also very clear that she wanted to help other people,” Harmatz said. “One of the joys of our work is when we’re working with a client who sees the opportunity to not just help themselves but to help other similarly situated people, and she really wanted to do something systemically.”
A systemic approach was important since hepatitis C is the nation’s leading blood-borne infection, affecting about 3.5 million Americans and killing nearly 20,000 every year.
For that reason, Coursolle had been following Medicaid coverage of drugs offering a cure ever since they came on the market in 2013. The drugs, called direct-acting antivirals, are close to 95 percent effective. They are also expensive. Viekira Pak, the drug Goldstein had been prescribed by her doctor, cost up to $31,000 a month at the time, and the course of treatment was three months.
Early on NHeLP had advocated with the Centers for Medicare & Medicaid Services (CMS), the federal agency that oversees the Medicaid program, asking them to inform states that they had to make direct-acting antivirals more widely available, in accordance with medical guidelines. In 2015, CMS did just that.
“At that point, once we saw certain states that were either very slow to implement the guidance from CMS or completely refusing, we felt like a litigation strategy could be appropriate to enforce the law in states that were still not making treatment available,” Coursolle said.
Rather than immediately filing suit in federal court, however, Goldstein’s legal team opted initially to conduct discovery at the administrative hearing level. Based on what they learned, they sent AHCA a demand letter, putting the agency on notice that it was in violation of the federal Medicaid Act. The letter demanded that AHCA change its policy and gave a realistic deadline.
The legal aid attorneys were pleasantly surprised with the response.
As of June 1, AHCA no longer requires evidence of advanced liver fibrosis for patients to receive curative hepatitis C treatment.
“Once they took the time to engage with us it was clear that the staff at the state really understood the issue and were willing to work with us to try to do the right thing,” Coursolle said.
Having completed her treatment in September, Goldstein is starting to feel better, and the virus is no longer detectable in her blood. She now knows she’ll be able to go on caring for her aging parents. And she’s looking forward to having more energy for pickleball, a sport somewhat like badminton or tennis that’s her main social outlet.
She also wants to continue doing what she can to help those denied their medications for other conditions.
“It was so wrong. The whole thing was so wrong,” she said. “If I had breast cancer would they wait until I had stage four cancer until I got treated? I don’t think so.”
Fried, whose research has contributed to the development of direct-acting antivirals, had advised Goldstein’s legal team on the health consequences of delaying treatment.
“The policy about waiting until people get advanced fibrosis was groundless, and it was solely based on financial considerations. There was no medical reason why you would wait for people to get worse,” he said. “The other complications are way more costly than a one-time course of treatment. But payers are looking at the annual budget. They’re not necessarily looking at what happens 10 years from now.”
What sets direct-acting antivirals apart from other treatments, he said, is that they can cure a patient in a relatively short period of time, as opposed to medications patients have to take for life.
“Because the medicines are so effective, they are really very cost-effective,” he said.
In fact, it’s conceivable that in the not-too-distant future the cost to society of treating hepatitis C could be drastically reduced. That’s because with the arrival of direct-acting antivirals, the Centers for Disease Control and Prevention, the Institute of Medicine and other groups are working on a national strategy for eradicating hepatitis B and C. The cost of treatment, meanwhile, has fallen by as much as 50 percent thanks to negotiated rebates and competition.
In spite of the long-term benefits, a 2016 study reported in the journal Viral Hepatitis found that at least 30 percent of Medicaid beneficiaries with hepatitis C who request a new breakthrough drug are denied access to treatment.
But thanks in large part to legal advocacy, that’s changing.
Fried said Medicaid programs and other payers around the country, including Blue Cross Blue Shield of North Carolina and the state’s Medicaid program, are following the lead of states like Florida and eliminating barriers to treatment.
“We’re starting to see some loosening of many restrictions,” he said. “You can attribute that to the success of these kinds of cases.”