ACLU Files Class Action Lawsuit Against Colorado Medicaid Over Unlawful Hepatitis C Treatment Restrictions
from Jules: I said 3 years ago lawsuits were the only way to address the restrictions, its taken 2+ years for these lawsuits to get rolling & the plaintiffs mostly settle with the States for inadequate arrangements like in Delaware where they settled with the State to fully lift restrictions in 2 years, ineffective advocacy & lawyering.
FOR IMMEDIATE RELEASE
September 19, 2016
John Krieger, Communications Director
Mark Silverstein, Legal Director
DENVER - The ACLU of Colorado filed a federal class action lawsuit this morning on behalf of thousands of low-income Coloradans suffering from Hepatitis C who are being denied life-saving treatment due to Colorado Medicaid restrictions that force them to incur serious harm to their health before gaining access to the cure.
"Federal law requires state Medicaid agencies to pay for medically necessary treatment, but Colorado Medicaid illegally denies a cure for Hepatitis C for reasons that are not medically justified," said Mark Silverstein, ACLU of Colorado Legal Director. "We are challenging a policy that forces Coloradans who cannot afford private insurance to live with the serious negative health effects of Hepatitis C and to wait for a cure, possibly for years, until they have suffered measurable and potentially irreversible liver damage."
Hepatitis C is a life-threatening, communicable disease that attacks the liver. It is the most deadly infectious disease in the U.S., killing more Americans than the next 60 infectious diseases combined. Even in the initial stages of the disease, Hepatitis C can cause serious symptoms, including fatigue, joint pain, depression, arthritis, as well as an increased risk of heart attacks, diabetes, nerve damage, jaundice, and various cancers.
Breakthrough medications approved by the FDA over the last three years cure Hepatitis C in more than 90 percent of cases. These treatments are available without restrictions for patients covered by Medicare, the Veterans Administration, and the overwhelming majority of commercial health insurers in Colorado.
There are approximately 14,400 low-income Coloradans infected with Hepatitis C who rely on Medicaid for healthcare. Federal law requires state Medicaid agencies to provide "medically necessary" services and treatments. Last November, the federal agency responsible for administering Medicaid issued guidance advising all state Medicaid agencies to provide access to the new treatment without imposing unreasonable restrictions.
For years, Colorado Medicaid required patients to demonstrate significant scarring on their liver, as indicated by a "fibrosis score" of F3 or higher on a F0 to F4 scale, before gaining access to treatment.
In July, the ACLU of Colorado wrote to the Colorado Department of Healthcare and Policy Financing (HCPF), the agency responsible for setting state Medicaid policy, to urge coverage of all patients regardless of "fibrosis score."
"Providing full access to Hepatitis C treatments is the fiscally sound decision for Colorado Medicaid, because early treatment precludes expenses that would otherwise be incurred as a result of the disease's progression," the ACLU wrote in the July letter. The ACLU also noted that a federal court in Washington had recently ordered that state to lift restrictions similar to Colorado's after concluding that treatment was medically necessary for all patients with chronic Hepatitis C infections.
Earlier this month, HCPF altered its policy to include patients with a fibrosis score of F2, an intermediate level of liver scarring, and added an ambiguous new exception for women of childbearing age who inform Medicaid that they plan to get pregnant in the following year.
"The latest policy change is a half-step that falls short of what the law requires, which is full access to medically necessary treatment for all patients with Hepatitis C," said ACLU of Colorado Staff Attorney Sara Neel. "The ill-conceived pregnancy exception perversely incentivizes women to either commit to get pregnant or to lie to their doctor about their family planning decisions in order to gain access to treatment."
Robert Cunningham, a Denver resident, is the named plaintiff and class representative in the suit. He was diagnosed with Hepatitis C in 2004 and has been denied access to treatment by Colorado Medicaid because his fibrosis score is F1.
"Everyone should have the right to treatment that can cure them. It should not be just reserved for some segments of the country, with the poorest being forced to wait and suffer," said Cunningham. "I want to get healthy, and I want to give people like me a voice and help the system to change."
The class action lawsuit was filed this morning in federal district court. Attorneys representing Cunningham and the plaintiff class include Silverstein and Neel, Kevin Costello from the Harvard Law School Center for Health Law and Policy Innovation, and ACLU cooperating attorneys Lawrence W. Treece and Lauren E. Schmidt of Brownstein Hyatt Farber Schreck LLP.
View the ACLU complaint:
View the ACLU's July letter to Colorado HCPF:
ACLU sues Colorado Medicaid over denial of treatment for thousands of hep C patients
Colorado's Medicaid department was slapped with a federal class-action lawsuit Monday led by a Denver man denied treatment for the life-threatening hepatitis C virus because he has government insurance.
Robert Lee Cunningham, represented by ACLU Colorado, is among thousands of Coloradans denied access to a breakthrough drug with a 90-percent cure rate because under Medicaid policy, he "has not yet suffered measurable and potentially irreversible liver damage," the lawsuit says.
Colorado covers the 12-week, $40,000 prescription only for people whose livers have reached stage two in scarring, on a scale of zero to four. Private insurance companies, however, cover the drug treatment for patients infected with the blood-borne virus, regardless of how far it's advanced.
The Colorado Department of Health Care Policy and Financing, which runs the Medicaid program, was criticized in recent months by the ACLU and Denver Health Medical Center regarding the policy. Following the scrutiny and a recommendation from the state drug review board, the department expanded coverage Sept. 1 to allow people in the second stage of liver scarring to receive the drug. It previously required that patients had to reach stage 3 in order to get the prescription.
The new policy also expanded coverage to women who plan to become pregnant within the next year, and it loosened a previous restriction barring anyone who used alcohol or illegal drugs within the previous six months. Now people with a history of chronic substance abuse will have to enroll in drug treatment counseling at least one month before receiving the hepatitis C regime.
But that expansion didn't go far enough, said ACLU of Colorado legal director Mark Silverstein. "We are challenging a policy that forces Coloradans who cannot afford private insurance to live with the serious negative health effects of hepatitis C and to wait for a cure, possibly for years, until they have suffered measurable and potentially irreversible liver damage," he said.
Denying the drug to needy Coloradans who have Medicaid while others with private insurance have access is illegal and against federal and medical guidelines, the lawsuit says. Medicaid beneficiaries are "being unduly subjected to a second-class standard of health insurance coverage for the sole reason they are poor," it says.
And allowing it for women who plan to get pregnant within a year raises questions about what proof doctors would require and whether it's fair to ask women to consider pregnancy in order to get a potentially life-saving drug, say critics.
Cunningham, 61 and a construction worker with three children and five grandchildren, was diagnosed with the virus in 2004 and a biopsy found his liver is at stage one. The disease makes him feel exhausted, and his muscles and joints - especially his knees - ache, he told the Denver Post. "The exhaustion and the pain make it hard for me to work and to live, but I have to work to make a living," he said.
Cunningham tries to keep his liver healthy by avoiding fried foods and alcohol, and has often has to assuage the fears of family members and new people he meets about how the disease is spread (through blood, mostly needles and transfusions). "It is very stressful because I don't know when the disease is going to take off and progress and that makes me feel anxious all the time," he said. "If the disease progresses to another level and it's irreversible, that is really stressful for me. I feel like I'm walking on a tightrope all the time where at any minute something bad could happen."
The lawsuit, which names Susan Birch, health care policy and financing executive director, seeks a permanent injunction barring the state from denying access to new antiviral medications. Before these new drugs began arriving on the market in 2013, the best treatment option included toxic injections that went on for a year, had an estimated cure rate of only 50 percent and came with debilitating side effects.
State officials have called their updated policy "reasonable" and based on clinical data that some people with hepatitis C never advance beyond stage one. The Medicaid department, which received the lawsuit Monday morning, did not immediately offer a comment.
The state counts 14,400 Coloradans with Medicaid who are infected with the blood-borne virus. An estimated 70 percent of those have liver disease at stage two or higher. So far, Colorado's Medicaid department has treated 413 people with the drug at a cost of $35.8 million, not including the undisclosed rebates it receives from drug companies.
Hepatitis C is the most deadly infectious disease in the United States, according to the Centers for Disease Control and Prevention.