Inside Health Policy: Researchers: Sovaldi Analysis Could Be Used In Lawsuits Against Medicaid

This article was originally published in Inside Health Policy on September 24, 2014.

Researchers: Sovaldi Analysis Could Be Used In Lawsuits Against Medicaid

Researchers at Harvard and Brown universities are analyzing state Medicaid programs’ coverage restrictions for the expensive hepatitis C drug Sovaldi, and the findings could lay the groundwork for beneficiaries to sue states, although a Harvard law instructor said legal action is a last resort. Patient advocates are especially angry at states that refuse to give the hepatitis C drug to alcoholics and drug addicts, arguing the policy is discriminatory and has no medical basis.

Malinda Ellwood, clinical instructor of law at Harvard’s Center for Health Law and Policy Innovation, stressed that the findings are preliminary; researchers must verify them with states and some states are still considering restrictions. Researchers are starting with Medicaid fee-for-service and hope to analyze prescribing restrictions in other areas, such as Medicaid managed care and states’ policies on who can treat patients with both hepatitis C and HIV.

Researchers found 30 states with prior authorization restrictions, which vary widely.

The majority of those 30 states restrict the drug to people with alcohol or drug-abuse problems. Among them, 12 states require that patients be sober and off street drugs for six months or longer before they qualify for Sovaldi, Ellwood said. Six states have abstinence periods between one month and three months, and five states require either abstinence or that patients be in treatment programs.

Lynn Taylor, assistant professor of medicine at Brown University, said she is appalled by states that withhold the drug from people with alcohol and drug addictions. African Americans are twice as likely to get infected by hepatitis C, according to the Centers for Disease Control and Prevention, and abstinence restrictions sharpen health care disparities between the poor and the rich, Taylor said. (Harvard and Brown researchers are both analyzing Medicaid restrictions by state and may jointly publish their results, Ellwood said.)

There is no medical reason for abstinence restrictions, Taylor argued, adding that some physicians mistakenly believe that people with alcohol and drug addictions are less likely to stick to their drug regimen. Not only is there no evidence of that, Taylor said, there do not appear to be any other diseases for which Medicaid refuses to cover treatments due to alcohol or drug use.

Taylor said it’s wrong to penalize patients who are trying to beat addiction by refusing to treat a separate condition. The rational she heard from states is that drug users may reinfect themselves. However, she said research established long ago that a small percentage of patients get reinfected. It’s not right to deny treatment to an entire population because of a few, she added. Reinfection is also a problem for other diseases, she noted, and the government doesn’t ration treatments for those infections with restrictions on alcohol and drug use.

Although Taylor dislikes all types of restrictions, she said she understands why states are prioritizing treatment to those who are sickest to deal with Sovaldi’s price, which costs $84,000 per course. FDA is expected to approve next month a second drug by Gilead Sciences that will be combined with Sovaldi in a single pill, which is expected to add significantly to the treatment’s cost. That pill will not need to be taken with interferon, which makes many patients very ill, so it is expected to be a sought-after treatment. Also, Sovaldi already cures more than 90 percent of many types of patients, and the combo pill is expected to have an even better cure rate and to reduce the treatment period from 12 weeks to as few as four weeks.

All 30 states require that patients show some degree of sickness, and most require a metavir score of at least F3, which requires a liver biopsy, before their Medicaid programs will cover Sovaldi, Ellwood said.

Natarajan Ravendhran, chief of gastroenterology and liver disease at St. Agnes Hospital in Baltimore, said it’s wrong to require such an invasive procedure to check on the severity of a disease to determine whether patients may receive a cure. Also, it’s not clear when someone crosses from stage two to stage three liver disease, and it’s difficult to time when to do follow-up biopsies to monitor the progress of liver disease. He said the restrictions often put both patients and their doctors in a difficult position, and he gave as an example one of his patients who is in stage one and wants to have children but cannot until her disease gets bad enough to merit treatment.

Ellwood said 21 states also restrict who may prescribe Sovaldi. That’s concerning because there may not be enough specialists to prescribe the drug to those who need it. Nine states require that specialists prescribe hepatitis C drugs, and 12 states require that prescribers consult with specialists.

The university researchers are working with National Viral Hepatitis Roundtable, which has called on HHS Secretary Sylvia Burwell to convene a meeting among drug makers, plans, patients and providers to figure out how to make Sovaldi available to everyone infected with hepatitis C. Patient groups are considering suing Medicaid programs in states with particularly strict limits on Sovaldi, but Ellwood said the group she is working with prefers solutions to lawsuits.

States are in a particularly difficult position. There is a high rate of infection among Medicaid beneficiaries and prison systems. Also, states must balance their budgets each year so even though Gilead priced its drug commiserate with the current cost of treatment, those costs are all up front and states cannot stretch them out over the 20 year to 30 years that they normally would have had to cover those costs.

John Wilkerson (

Food Law and Policy Clinic Announces Harvard iLab Deans’ Food System Challenge

FB_logoThe Food Law and Policy Clinic (FLPC) is thrilled to announce the Harvard iLab Deans’ Food System Challenge. The Challenge invites creative and entrepreneurial students to develop innovative ideas to improve the health, social, and environmental outcomes of the food system in the United States and around the world.

Each year the Harvard Innovation Lab (i-Lab), a cross-University resource serving Harvard students interested in innovation and entrepreneurship, organizes a series of Dean’s Challenges that encourage students from across the university to develop innovative solutions to pressing social issues. This will be the first Dean’s Challenge sponsored by Harvard Law School Dean Martha Minow, who is co-sponsoring the Challenge with Dean Julio Frenk of Harvard T.H. Chan School of Public Health. Attorneys and students from the FLPC and the Center for Health Law and Policy Innovation have been thrilled to work with Dean Minow to develop and plan this Challenge.

The Challenge seeks proposals for ideas in the following four topic areas: (1) Producing Sustainable, Nutritious Food, (2) Innovating in Food Distribution and Markets, (3) Improving Our Diet, and (4) Reducing Food Waste. We invite students, faculty, and others engaged in the food system to have an open dialogue and provide feedback on Challenge contestants’ ideas through our online crowd-sourcing platform (coming soon). To learn more about the Challenge, click here.

The Deans’ Food System Challenge will officially kick off on October 27, 2014. The kick-off will feature Dean Minow and keynote speaker Ayr Muir, founder and chief executive of Clover Food Lab. This event aims to bring together students, faculty, and members of the Harvard community to celebrate the start of the Challenge, discuss pressing issues in the food system, and create new networks in our community. Space for the event is limited; please register here.

In conjunction with the Challenge, there will be a year-long Food Better events series that aims to raise awareness about issues in the food system, highlight the important food system work being done across the University, and connect potential teammates for the Challenge. The Food Better Campaign will launch the week of September 29th, with events every day that week and a larger launch event on October 3rd, including a panel of food entrepreneurs and student leaders, followed by a brainstorming session and a reception at Queen’s Head Pub. All students are invited to participate.

CHLPI Welcomes New Clinicians Katie Garfield and Carmel Shachar

The Center for Health Law and Policy Innovation welcomes new staff clinicians Katie Garfield and Carmel Shachar to the team.

K Mathis HeadshotKatie Garfield
Clinical Fellow in the Health Law and Policy Clinic

Katie joined the Harvard Law School Center for Health Law and Policy Innovation as a Clinical Fellow in September 2014. Katie earned her J.D. from Harvard Law School, cum laude, in 2011, where she served on the Board of Student Advisers. Katie is a licensed member of the Massachusetts bar.

Prior to joining the Center, Katie was an associate in the litigation department of Ropes & Gray LLP. While at Ropes & Gray, Katie worked on a variety of matters, including advising clients in the pharmaceutical and medical device industries on issues related to promotional practices, regulatory compliance, and anti-corruption laws. She also co-authored an article with her colleagues at Ropes & Gray regarding developments in the classification of Qualified Health Plans in Law360. Prior to joining Ropes & Gray, Katie spent a year working in the Housing Unit of Greater Boston Legal Services as part of the Ropes & Gray New Alternatives Program. At GBLS, she represented low-income families with dependent children who were seeking to gain or retain access to Emergency Assistance shelter benefits. Katie received a B.A. in English Language and Literature from Yale University, summa cum laude, in 2007 and an MPhil in Medieval Literature from the University of Cambridge in 2008.


Carmel Shachar HeadshotCarmel Shachar
Staff Attorney in the Health Law and Policy Clinic

Carmel joined the Harvard Law School Center for Health Law and Policy Innovation in September 2014. Carmel earned her J.D., cum laude, in 2010 from Harvard Law School and her M.P.H. in 2010 from the Harvard School of Public Health. She clerked for Judge Jacques L. Wiener, Jr. of the U.S. Court of Appeals for the Fifth Circuit from 2010-2011. Carmel is a licensed member of the bars of the State of New York and the Commonwealth of Massachusetts.

Prior to joining the Center for Health Law and Policy Innovation, Carmel was an associate in the health care group of Ropes & Gray LLP. She focused her practice in regulatory and compliance work, including advising client on topics such as data privacy and security, implementation of health care reform and public payer billing and reimbursement. Carmel has significant experience advising on managed care network construction, regulation and strategy for non-profit and for profit clients. She also served as temporary-in house counsel to a large medical device company. During her time at Ropes & Gray, she authored two articles on Medicaid premium assistance programs in Bloomberg BNA’s Health Care Policy Report, an article on the placement of laboratory staff in physician offices in G2 Intelligence and an overview of data privacy and security regulations for health insurance exchange entities in Bloomberg BNA’s Health IT Law & Industry Report.

Greensboro News & Record: Another reason to expand Medicaid in NC: Rising cost of treating diabetes

September 3, 2014

The following editorial appeared in the Greensboro News & Record:

Diabetes is a costly epidemic in North Carolina, and it is rapidly expanding. That’s a disturbing finding headlining a report by Harvard University researchers released earlier this year.

While North Carolina is fortunate to be the focus of a diabetes study by the Center for Health Law and Policy at Harvard Law School, the reason for the attention is ominous: North Carolina has a huge problem.

The rate of diabetes here has doubled over the past 20 years. It is the seventh-leading cause of death in the state – and it’s more deadly than that for African-Americans and American Indians. By 2025, if this trend continues, diabetes will take many more lives and “cost the state’s public and private sectors more than $17 billion per year in medical expenses and lost productivity,” the report says.

Risk factors include being overweight, exercising too little and having high blood pressure and cholesterol levels. Lifestyle choices are important for reducing risk or managing the disease.Unfortunately, the authors say, many North Carolinians lack access to medical care or programs that help them reduce risk or manage disease.

They recommend a number of policies to improve those conditions. One, already rejected by political leaders, is broadening Medicaid eligibility. This report gives another reason to reconsider.

North Carolina already operates some programs targeted at diabetes, but much more should be done, the report says.

The state needs to build a “whole-person model of diabetes care,” requiring lifestyle modification and management services, primary and specialty medical care and access to community resources ranging from healthy food options to financial assistance to opportunities for physical activities.

The YMCA of Greensboro recently announced it will participate in a nationwide diabetes prevention program, offering classes to help people reduce their risk. Community initiatives like this can have a big impact.Statewide, coordinated care models can help – Community Care of North Carolina’s diabetes management program saved the state $1.5 billion in Medicaid expenses from 2007 to 2009, the report says – but too many people don’t fit into them.

The 150-page report is full of detailed analysis and recommendations for battling this disease. In debates about Medicaid costs, the Affordable Care Act and state budget issues, there’s been hardly any mention of diabetes care. So this comes as an important reminder that people’s lives are at risk and that such a serious threat to good health poses a big financial liability.

If policymakers want North Carolina to be an attractive location for businesses, they should pay attention to diseases that rob the workforce of its vitality and cost employers more money in insurance costs, productivity and taxes for public health.

North Carolina’s supposedly healthy business climate depends on the good health of its population.

Link to the article here.

FLPC Joins the UN Zero Hunger Challenge

FLPC_ZeroHungerChallenge_1 pager

The Food Law and Policy Clinic is thrilled to become a participant in the United Nations Zero Hunger Challenge: an initiative to eliminate hunger worldwide. The UN Secretary General Ban Ki-moon launched the Zero Hunger Challenge at the Rio+20 Sustainable Development Conference in June 2012, and over 50 organizations have signed on to participate in the Challenge. As a participant in the Zero Hunger Challenge, FLPC will join efforts to “ensure that every man, woman and child enjoy their Right to Adequate Food; women are empowered; priority is given to family farming; and food systems everywhere are sustainable and resilient.”

Our Zero Hunger Pledge describes how FLPC’s current and future work promotes the Challenge’s five principle goals:
1. Zero stunted children less than 2 years;
2. 100% access to adequate food all year round;
3. All food systems are sustainable;
4. 100% increase in smallholder productivity and income; and
5. Zero loss or waste of food.

Please read our Pledge to learn more about FLPC’s work, and visit the UN Zero Hunger Challenge to learn more about our great partners and this important collaborative effort.