FLPC Welcomes Visiting Scholar Cameron Faustman

Cameron Faustman. (Peter Morenus/UConn Photo)

Professor Cameron Faustman has spent his 30 year academic career in the College of Agriculture, Health and Natural Resources, University of Connecticut (UConn).  His teaching and research activities have focused on the fundamental science associated with quality, preservation and safety of food, particularly foods of animal origin. 

He is grateful for the opportunity to spend his Spring 2019 sabbatic leave at the FLPC.  His administrative experiences at UConn have provided him with an appreciation for the impact of sound policy on food, health and the environment.  He was attracted to the FLPC after learning of their efforts with policy activities concerned with food waste.  Cameron seeks to learn how policy is created and implemented as a complement to his understanding of the science of food. 

As an active researcher, he has published more than 120 scholarly manuscripts, books/book chapters, and conference proceedings; his work has been referenced sufficiently to place him in the top 1% of cited authors in all of Agriculture.  He has provided more than 50 invited lectures and visited 9 different countries in that capacity, and served on the editorial boards of 4 different scholarly journals.  He received the UConn Teaching Fellow (1996) and the USDA Northeast Excellence in Teaching (1999) Awards, the highest levels of recognition for teaching excellence at UConn, and regionally in agriculture science, respectively. National recognition of his research accomplishments includes the 1994 American Meat Science Association (AMSA) Achievement Award, 2000 AMSA Research Excellence Award, 2009 Institute of Food Technologists’ (IFT) Food Chemistry Division Lectureship Award, and the IFT Stephen Chang Award for Lipid or Flavor Science Research (2010). 

A faculty member in UConn’s Department of Animal Science since 1989, he served as Head of the Department of Animal Science (2000-04), Associate Dean for Academic Programs and Research (2005-16) and as Interim Dean (2017-19).  He earned his B.S. from the University of Connecticut (1982), and M.S. (1987) and Ph.D. (1989) degrees from the University of Wisconsin-Madison.

Outside of the world of food he enjoys flyfishing, hiking, biking, photography and a seat near a wood-burning stove.

 

Tough Choices Over a Pricey But Effective Drug for Hepatitis C

Originally published by StarTribune on January 28, 2019. Written by Glenn Howatt.

Hepatitis C is one of the most common infectious diseases, with the potential to cause serious liver damage, so patients were thrilled when a set of revolutionary new medications became available five years ago. But at $90,000 per treatment course, the drugs were pricey, and many states, including Minnesota, balked at covering them under their taxpayer-funded Medicaid programs.

Since then, however, the treatment cost has fallen dramatically — in some cases to $24,000 — and is expected to fall further after generics are introduced this year. Now advocates are urging Minnesota to drop its restrictions, which they say prevent patients from getting medications that are highly effective and stop the spread of the virus. “I am frustrated seeing my patients walking around with infections that I could treat with a snap of my finger,” said Dr. Ryan Kelly, a primary care physician at the Community-University Health Care Center in Minneapolis.

Minnesota is one of only 12 states that require patients with an addiction history to maintain a six-month period of sobriety before they can start taking hepatitis C drugs, although some can get the medication with three months’ sobriety if they are in addiction treatment. By comparison, 32 states either have no sobriety restrictions or require basic screening and counseling to weed out patients who are not good candidates for treatment.

Kelly plans to meet soon with officials at the Minnesota Department of Human Services, which runs the Medicaid program, in an effort to change its policy.

Nearly 35,000 infected

The current restrictions, which also require that the drugs be prescribed only by or in consultation with a specialist, such as a gastroenterologist or hepatologist, were introduced when the new treatments came online in 2014. Nearly 35,000 people in Minnesota are infected with hepatitis C, according to the Minnesota Department of Health. On average, 2,200 people in the state are diagnosed with the virus every year, but the state can’t say when they acquired the infection. Disease researchers say that many more are infected but have never been tested.

Hepatitis C, which can lead to liver cirrhosis and cancer, is spread mainly through blood. Many infections are caused when street drug users share needles. “Hepatitis C is on the rise mostly because of the rise in injecting drug users,” said Kelly. “If we treated people who are spreading the infection, more costs would be saved down the road.”

A state official says the sobriety restrictions are necessary to prevent people from becoming reinfected should they relapse after getting hepatitis C treatment. “We want them to be treated in a way that will be successful,” said Dr. Jeff Schiff, medical director for Medicaid and MinnesotaCare. “The cost has come down significantly, but it is still a very significant cost per treatment course.”

Kelly said the decision to prescribe hepatitis C treatment drugs should be left to the doctor who knows the patient best. As with other diseases, doctors weigh many factors before writing a prescription, including the patient’s likelihood to comply with the treatment. “It is a moral restriction that has nothing to do with [patient] health and doesn’t need to be there,” he said.

Schiff said he’s open to a discussion about the future of the state policy. “The landscape is evolving since these [drugs] came on the market,” he said. “Through our internal conversation we have decided that we will take another look at this policy.” 

Sober for his daughter

Gabriel Bliss, 31, has been waiting since April to get the medications that will cure his hepatitis C. He had been a long-term heroin user but quit after his best friend died from a batch that contained fentanyl. He learned of his hepatitis infection while in detox. “I have a 3-year-old daughter, and she is the main reason that I am still alive and the main reason that I am sober,” he said in a recent interview at his Richfield house.

Bliss gets his insurance through one of Minnesota’s Medicaid managed-care plans, which administer benefits to about 850,000 of the 1.1 million residents who are on the program. All of them have similar restrictions to the state policy. After quitting heroin, Bliss saw a specialist but got turned down for hepatitis meds because he had smoked marijuana.

“I figured that if I wasn’t on other hard drugs it would be OK,” he said. “Had I known that, I wouldn’t have smoked, because it is a lot more important for me to get rid of hep C.” Now, he has to wait until March before getting treated. In the meantime, he’s concerned that he might infect others, either through an open wound or even sexual contact, which presents a low risk. “I don’t know why there are restrictions on it,” he said. “You would think that you want people to be healthy because it would cost less in the long run.”

Nationwide, state Medicaid programs are being urged — and sometimes sued — to drop treatment barriers. Led partly by the Center for Health Law and Policy Innovation at Harvard University, 21 states have dropped or reduced requirements that patients must suffer some liver damage before they are treated, a requirement that Minnesota never used.

Nine have relaxed sobriety restrictions, and six have loosened specialist requirements. 

“What we are seeing here are measures that are deliberately put in place to stop people who need medically necessary care versus cost concerns,” said Phil Waters, an attorney with the Harvard center. He said the restrictions are “discriminatory and illegal.”

An ‘early win’

Phil Gyura, a certified nurse practitioner with Minneapolis-based Livio Health, used to practice in New York. He said access to treatment expanded significantly when that state dropped most of its restrictions in 2016. “From a public health standpoint, the more people that we cure, the less likely it is to spread,” said Gyura, director of addiction care and behavioral health integration at Livio.

He said Minnesota has a unique opportunity to expand hepatitis C treatment because so many people get drug or alcohol treatment in centers. “They have the nursing staff and they have the structure,” he said. “It can be an early win in their sobriety.”

Both Gyura and Kelly said most of their patients want to get treatment directly from a primary care doctor rather than a specialist. “I see many people at my clinic who view our clinic as their medical home,” Kelly said. “Being referred to a different clinic to see a specialist, especially to a confusing large hospital system, is a huge barrier.”

Schiff said state policy would allow patients to consult a specialist electronically, without visiting an unfamiliar clinic or hospital. “It would be relatively easy for that provider to get on a telemedicine platform … and do that consultation in real time,” he said.

Nonetheless, critics of the specialist requirement say it hearkens back to the days when the only treatment for hepatitis C involved toxic intravenous drugs, which also weren’t as effective as the newer pills. “It has become much less complicated to treat,” Kelly said.

 

FLPC Seeking Research Assistant (Open to HLS Students Only)

The Food Law and Policy Clinic (FLPC) serves partner organizations and communities by providing guidance on cutting-edge food system issues, while engaging law students in the practice of food law and policy. Specifically, FLPC focuses on increasing access to healthy foods, supporting sustainable production and regional food systems, and reducing waste of healthy, wholesome food.

With its comprehensive work related to U.S. laws and policies of food donations, FLPC is launching an exciting and first-of-its kind project that will bring its expertise to other countries. In collaboration with the Global FoodBanking Network, FLPC is beginning to research more than a dozen foreign legal systems to better understand how they encourage or discourage food donations. Ultimately, through this partnership and extensive stakeholder engagement, FLPC intends to publish legal guides that communities in these countries can use to better navigate the laws and policies of food donations.

FLPC seeks a research assistant (RA) for a paid position to help with legal research for this project. For spring 2019, our particular focus will be on the laws and policies of Argentina, Chile, and Mexico.

Under the supervision of FLPC staff, the RA may:

  • Research tax incentives and dis-incentives for food donations, including VAT, tax deductions and tax credits, and other tax policies
  • Research civil and criminal liability related to food donations
  • Research food labels and other related food-safety laws and policies
  • Work with the FLPC team on drafting and revising country-specific legal guides

Qualifications

  • Fluency in Spanish
  • Ideally, a thorough understanding of Latin American laws and institutions
  • Interest in food and public health law and policy
  • Strong writing and research skills
  • Enrolled at Harvard Law School

 How to Apply

Applicants must submit (1) a cover letter, (2) a resume, and (3) a writing sample to bfink@law.harvard.edu.

RAs must have the ability to be employed in the United States.  The position is part-time and the time commitment can be flexible.

For more information, please e-mail bfink@law.harvard.edu.

CHLPI Welcomes New Team Member Kristin Sukys

The Center for Health Law and Policy Innovation (CHLPI) and the Health Law and Policy Clinic welcome Kristin Sukys to the team as a Policy Analyst!

Kristin joined the Center for Health Law and Policy Innovation at Harvard Law School as Project Consultant in August 2018 leading the GIS analysis for the Massachusetts Food is Medicine State Plan and is currently a Policy Analyst working on HLPC’s whole-person care initiatives.

Kristin graduated in May 2018 with a Masters of Science degree in Agriculture, Food, and Environment from the Friedman School of Nutrition Science and Policy at Tufts University. Specializing in community food systems and public health, her work focused on the intersection of our health care and food systems. Prior to graduate school, she received a B.A. in International Relations specializing in Environmental Issues from Virginia Tech.

 

 

FLPC Seeking New Clinical Instructor

Come work with us at the Harvard Law School Food Law and Policy Clinic!

Reporting to the Director of the Food Law and Policy Clinic (FLPC), the Clinical Instructor will work independently and with Clinic staff and students on a broad range of international, federal, state, and local food policy projects. Founded in 2010, FLPC is at the forefront of utilizing creative teaching, scholarship, and student engagement to tackle complex food law and policy issues.

FLPC serves partner organizations and communities by providing guidance on cutting-edge food system challenges, while teaching law students about substantive food law and providing them with skills around problem-solving, policy development, community organizing, and systemic change. FLPC focuses its efforts on increasing access to healthy foods, supporting sustainable production and regional food systems, and reducing waste of healthy, wholesome food. The Clinical Instructor will be an integral part of the Food Law and Policy Clinic team, providing leadership on projects, vision for future initiatives, and hands-on teaching with clinical students.

The Clinical Instructor’s work will entail:

  • Developing and overseeing the work on one or several FLPC initiatives, which includes developing specific projects within the initiative and directing the project work within that initiative, managing relationships with clients and partners, staying abreast of relevant developments in the field, and developing long-term strategic goals for the initiative;
  • Supervising clinical students and training these students on lawyering skills including problem-solving, law and policy analysis, research and writing, oral communication, and leadership;
  • Assisting with development and teaching of classroom courses offered in conjunction with the Clinic;
  • Delivering talks and trainings to clients, partners, and policymakers, and representing FLPC at local and national conferences and events;
  • Leading and supporting the administrative tasks of the Clinic, including conference and event planning, student outreach, communications, development, and other tasks that arise;
  • Working with the Director, helping to develop and implement the vision for the future success of the innovative food law and policy work conducted by FLPC.

JD Degree required, earned at least three years ago and a minimum of three years relevant experience.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.

For additional information and to apply: http://hr.harvard.edu/jobs/
Requisition #48082BR, Clinical Instructor, Food Law and Policy Clinic.

People in Puerto Rico Can’t Get the Same Hepatitis C Meds as Other American Citizens Do

Originally published by Tonic on January 2, 2019. Written by Carmen Heredia Rodriguez, Kaiser Health News.

Drugs that can cure hepatitis C revolutionized care for millions of Americans living with the deadly liver infection. The drugs came with a steep price tag—one that prompted state Medicaid programs to initially limit access to the medications to only the sickest patients. That eased, however, in many states as new drugs were introduced and the prices declined.

But not in Puerto Rico: Medicaid patients in the American territory get no coverage for these drugs.

The joint federal-territory healthcare program for the poor—which covers about half the island’s population—does not pay for hepatitis C medications. They also do not cover liver transplants, a procedure patients need if the virus causes the organ to fail.

The Puerto Rico Department of Health created a separate pilot project in 2015 to provide hepatitis C medications to those sickened by the liver infection who also have HIV, but expanded the program later to those with only hepatitis C. However, according to the Office of Patient Legal Services, an official territorial agency that advocates for consumers, the program ran out of funding and is no longer accepting patients only with hepatitis C.

The Puerto Rico Health Insurance Administration (ASES), which oversees Medicaid, says it is working with a pharmaceutical company to create a cost-effective system to provide these medications.

“Definitely, they need to be given coverage,” ASES director Angela Ávila Marrero says. “They need to be given care.”

The Department of Health did not comment.

Hepatitis C, a bloodborne infection, increases the risk of cirrhosis, liver cancer, and death. Poor screening led many to contract the disease through tainted blood and organ transplants through the early 1990s. Today, intravenous drug use drives most of the new cases in the United States.

William Ramirez, executive director of the American Civil Liberties Union of Puerto Rico, says he is considering filing suit against Puerto Rico for failing to cover the cost of these medications for people enrolled in Medicaid.

“You’re holding back medication and thereby allowing certain people to die,” Ramirez says.

That reality is clear for Hector Marcano, 62, who stopped working roughly six years ago because of the illness. After recovering from a drug addiction, he was a case manager who worked to connect drug users to health resources.

His liver disease is leading to overall deterioration. He struggles with walking. A bout of pneumonia that left him hospitalized lingers in his racking coughs. He spends his days reading, listening to the radio, and praying for the strength to keep searching for the cure.

He doesn’t understand why the government does not provide hepatitis C medications, he says, especially as there are so many people in need of them.

“So what are we waiting for?” asked Marcano. “For a pandemic to happen?”

Medicaid costs drive island’s debt crisis

Approximately 3.5 million people in the United States have hepatitis C. The virus can silently corrode the liver for years without causing symptoms.

Because of the condition’s stealthy nature and the absence of recent data, the number of people in Puerto Rico living with the virus is uncertain. Researchers on the island in 2010 estimated that 2.3 percent of 21- to 64-year-old residents had the virus.

Documents provided by the Center for Health Law and Policy Innovation of Harvard Law School show medical providers reported more than 11,000 hepatitis C cases to the Puerto Rico Department of Health from 2010 to September 2016.

Cynthia Pérez Cardona, an epidemiology professor at the University of Puerto Rico and an author of multiple studies involving hepatitis C in Puerto Rico, says she is uncertain of how widespread the virus is on the island. But other statistics present a worrisome sign: A report from the island’s cancer registry found the number of new liver cancer cases increased an average of 2.1 percent annually among men and 0.7 percent among women from 1987 to 2014. Hepatitis C can cause such cancers.

Despite these warnings, Puerto Rico has fewer resources than most of the nation to care for its impoverished.

Unlike states, Puerto Rico’s federal funding for Medicaid is capped. Historically, these federal dollars have fallen far short of covering the program’s costs on the island. The territory’s crushing Medicaid expenses helped drive the island into its $70 billion debt crisis.

Under these financial constraints, says Matt Salo, executive director of the National Association of Medicaid Directors, Puerto Rico’s officials are left with a difficult choice when considering covering hepatitis C drugs.

“Rather than blowing through their cap in six months,” Salo says, “they’d blow through their cap in one month.”

Pilot project falls short

In the health department’s pilot project, patients with certain conditions like uncontrolled diabetes or an active mental health condition or those who could not prove they had been sober for six months were barred.

Such restrictions rankle patients and their advocates. “You know, we do not deny lung cancer treatment for a person who smokes or diabetes treatment to a person that doesn’t eat well,” says Robert Greenwald, a professor at Harvard Law School and faculty director of the Center for Health Law and Policy Innovation.

José Vargas Vidot, a member of Puerto Rico’s Senate and a physician, submitted a petition in 2017 to various territorial agencies questioning Medicaid’s coverage of hepatitis C medications.

The Office of Patient Legal Services responded to Vargas Vidot in a letter this year confirming that the island’s Medicaid program did not cover these drugs. It also noted the health department pilot project closed its wait list after reaching 100 patients because of a lack of funding. In November, Vargas Vidot submitted legislation to require that hepatitis C medication and treatment be part of basic coverage for insurance plans and Medicaid.

Ávila Marrero says ASES is in talks with a drugmaker to create a network separate from the Medicaid program to provide medications to the patients. She is hoping the arrangement would allow the government to get lower prices for the drugs. But no agreements have yet been reached for such a program.

Despite its success in states, suing to get coverage may not be the best option for Puerto Rico because the debt rescue package passed by Congress in 2016 includes a provision that bars creditors from taking legal action to collect from the territory.

That could apply to a lawsuit filed against the territory for not covering hepatitis C treatment in its Medicaid program, says Phillip Escoriaza, an attorney in Washington, D.C., who practiced health law in Puerto Rico.

And even if the case can go forward, it would enter the docket for a special bankruptcy court with more than 165,000 other claims, as of January 2. It may be in the Puerto Rican government’s interest for things to take a long time, Escoriaza says. Once there, it could stall for years—time hepatitis C patients such as Marcano might not have.