Medicaid Is Tight on Hepatitis C Drug Coverage

Direct acting antiviral agents (DAAs) are remarkably effective for hepatitis C virus (HCV) infection, relatively free of adverse effects, the preferred method for treating patients, and very very expensive. The cost of a 12-week course of therapy initially exceeded US$100,000 and now lies in the range of US$60,000 to US$80,000. Perhaps it’s not surprising, then, that private insurance companies and state Medicaid programs balked at providing these drugs to their insured customers.

Ongoing “Battle for Coverage”[[{"type":"media","view_mode":"media_crop","fid":"58341","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_6904708499002","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"7375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 153px; width: 221px; border-width: 0px; border-style: solid; margin: 5px; float: right;","title":" ","typeof":"foaf:Image"}}]]

Initially, the “battle for coverage” pitted health care professionals advocating for their patients against state Medicaid programs and the private insurance providers. Usually, the health care professionals lost. This was all the more frustrating given that many health care professionals had been advising their HCV-infected patients to delay initiating treatment for 2 years or more until the more effective DAAs became available.

Each state Medicaid program is allowed by law (with some very important exceptions) to choose its own formulary and develop guidelines for the use of these drugs. Private insurance providers typically take the same approach to limiting the availability of very expensive drugs, even though the plans they offer are required under the Affordable Care Act (ACA) to meet certain minimum standards.

In addition, the federal government mandates that state Medicaid programs offer treatments that are “medically necessary” or “life-saving” or both to those who qualify by income for Medicaid.

Furthermore, under the ACA, public insurance programs are prohibited against “discriminating against patients on the basis of health status or diagnosis.” Nevertheless, many state Medicaid programs effectively denied patients access to the DAAs. The same was true for the private insurance companies and even the state drug assistance programs (Ryan White–funded) for HIV-infected patients, which often took their lead from the state Medicaid programs.

The “Tide” May Have Turned

But it appears that the “tide” has turned within the past year in favor of substantially easier access to the DAAs. What happened to effect this change?

First, both the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases stated in their guidelines that all patients who have HCV should be treated with the most efficacious drugs available.

Second, in the fall of 2015, the Obama administration wrote to state Medicaid programs that they may be violating federal law by restricting access to HCV medications.

Then, in May 2016, a US Circuit Court judge, in a lawsuit brought by a patient against the State of Washington, ordered that state to lift restrictions on coverage for the DAAs.

This was the first time a federal court had declared that placing “widespread” restrictions on HCV medications in a state Medicaid program was illegal. Subsequently, similar lawsuits brought against other state Medicaid programs were settled, resulting in broadening of the coverage for the DAAs. The private insurance companies quietly changed their coverage as well. Nevertheless, restrictions on coverage of the DAAs persist across state Medicaid programs and private insurance companies.

Next: Common Approaches to Coverage

Some Common Approaches to Medicaid Coverage

It is beyond the scope of this article to document the specifics of each state’s Medicaid programs, let alone the restrictions all the private insurance company policies place on these drugs, but a few common approaches to coverage of the DAAs are worth noting:

► State Medicaid programs and private insurance companies almost always, if not always, require very specific documentation of HCV status, including HCV RNA, liver fibrosis status, and HCV genotype.

► State Medicaid programs very often limit coverage to patients with fibrosis stages F3 and F4.

► Some state Medicaid programs (eg, Michigan) that limit coverage to fibrosis stages F3 and F4 allow coverage for patients with “significant” comorbid conditions, such as HIV, regardless of fibrosis stage. In those states, comorbid conditions also might include endocarditis, congestive heart failure, and diabetes.

► Some state Medicaid programs and private insurance companies require documentation of alcohol and other drug use abstinence for 3 to 12 months before authorizing coverage.

► Many state Medicaid programs, state drug assistance programs, and private insurance companies offer only 1 DAA, often because they have a preferred pricing contract with a particular pharmaceutical company.

► Quite a few state Medicaid programs require a specialist to prescribe the therapy or document a consultation with a specialist prior to authorizing coverage.

► Several Medicaid programs and private insurance companies allow only “once in a lifetime” treatment with DAAs.

► Some state Medicaid programs and private insurance companies require documentation of early virologic response to therapy, typically after 4 weeks.

► A few state Medicaid programs require documentation of vaccination against hepatitis A virus and hepatitis B virus (for example, Arizona, Colorado, Oklahoma, and West Virginia).

► Some state Medicaid programs and private insurance companies require medical provider–documented evidence of abstinence counseling, risk reduction counseling, or HCV educational counseling.

Note that most state Medicaid programs allow for an appeals process, typically involving physician-to-physician dialogue. The one time I [Rodger MacArthur] tried this approach with Michigan Medicaid, I was very impressed with the competence and understanding of the physician who ultimately authorized treatment.

Rapid Change and Myriad Differences

The bottom line: Insurance coverage for the DAAs is changing rapidly, with myriad differences among the state Medicaid programs and private insurance companies.

And while in most states we are a long way from coverage of the DAAs for all of the more than 3 million Americans who have active HCV infection, substantial progress has been made in the past year. More likely than not, the majority of persons infected with HCV in the United States already have, or soon will have, access to these life-saving therapies.

Coming soon, the next part of this Special Report on Hepatitis C and Primary Care will focus on treatment options. Watch your email for eNewsletters from Patient Care and visit our homepage at www.patientcareonline.com to check for updates.