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CHLPI Blog

As COVID-19 Pandemic Highlights Critical Importance Of Nutrition, BP Adams Releases a Report With Harvard Law School’s Food Law And Policy Clinic About Opportunities To Advance Nutrition Education For Physicians and Health Professionals

Today, Brooklyn Borough President Eric Adams and Harvard Law School’s Food Law and Policy Clinic released a report outlining policy opportunities in New York to advance nutrition education for physicians and health professionals. In the United States, poor diet is the most significant risk factor for premature death and disability. Although many people report that they think physicians are a trusted source of information on the relationship between diet and health, in actuality most physicians receive little to no formal education on nutrition. The ​report details several ways lawmakers can work with medical schools and similar institutions throughout the state to strengthen nutrition education requirements and ensure people in the health care professions are equipped with knowledge to better serve their patients. Armed with this knowledge, physicians will be able to include basic nutrition assessments during patient exams, respond more confidently to patient questions about food and diet, and be equipped to make necessary referrals for their patients.

Our office is currently in touch with various elected officials and advocates to discuss a legislative framework that would empower New Yorkers to lead healthier lifestyles. By working alongside medical schools and other partners on this issue, we hope to achieve the best possible health outcomes for our constituents.

Recognizing the ability of an optimal diet to prevent and treat many chronic diseases, the SUNY Downstate Health Sciences University created the Committee on Plant-based Health and Nutrition, a multidisciplinary effort by the College of Medicine, School of Public Health, and the Brooklyn Borough President’s Office.  Within the College of Medicine, students initiated the DINE Club (Downstate Initiative on Nutrition Empowerment) and a Lifestyle Medicine Interest Group (LMIG), the latter being the only official LMIG in the New York metropolitan region under the auspices of the American College of Lifestyle Medicine.  Together, these initiatives will help the population of Central Brooklyn, which suffers from one of the highest rates of diet-related illnesses in the entire city, prevent, treat, and potentially reverse, conditions that include diabetes, obesity, heart disease, and some cancers.

“The COVID-19 pandemic was a tragic reminder that when our most trusted health professionals are not informed on the connection between nutrition and health, we all suffer. These crises existed long before the arrival of coronavirus to New York, but the fact that some of the leading co-morbidities were diet-related diseases like obesity and diabetes only underscores the urgency of filling this knowledge gap and empowering people to heal themselves through their diets. I look forward to implementing initiatives and policies that better the education of medical workers and the health of New Yorkers,” said Brooklyn Borough President Eric Adams.

“Our health care system must acknowledge the role that food plays in chronic illness prevention and treatment, and to achieve that goal, we need to educate our doctors,” said Professor Emily Broad Leib of Harvard Law School’s Food Law and Policy Clinic. “Fortunately, as highlighted in our report, there are several policy opportunities to systematically improve nutrition education for physicians and health care providers, from providing financial or recognition incentives to medical schools to offer nutrition education programs, to creating a state office that would provide technical assistance for such programs, to specifying required courses in food and nutrition for physician licensure. We commend Brooklyn Borough President Adams for working to identify and advance the right policy solutions for New York.”

 “We are in complete agreement with the Harvard Food Law and Policy Clinic’s conclusions on nutrition’s critical role in chronic disease and the need for physician and health professional education in dietary lifestyle,” said ACLM President Dexter Shurney, MD, MBA, MPH, FACLM, DipABLM. “The pandemic has indeed highlighted that diet-related disease has made populations already experiencing health disparities even more vulnerable. The American College of Lifestyle Medicine exists to fill the gaping void in medical education for evidence-based Lifestyle Medicine therapies of predominantly whole food plant-based diet, regular physical activity, restorative sleep, stress management, avoidance of risky substances and positive social connection. We applaud and look forward to supporting the efforts of SUNY Downstate Health Sciences University and Brooklyn Borough President Adams to provide this critical training to help restore health.”

“This report contributes to the growing list of resources aimed at reducing the impact of heart disease, diabetes, and obesity through plant-based diet polices. This, together with the founding of the Committee on Plant-based Health and Nutrition, marks a substantial step forward for integrating diet concepts and strategies like these into public health practice” says Craig Willingham, Deputy Director, CUNY Urban Food Policy Institute.

“A nutrition prescription from a doctor is an opportunity to transform a patient’s serious illness to a success story. While seventy-three percent of physicians feel that patient visits should include nutrition guidance, only 15 percent feel “totally prepared” to offer it. It’s essential that we train and support clinicians in nutrition counseling: general nutrition throughout the lifecycle, nutrition assessment, the role of nutrition in disease prevention, management, and treatment are the basics our clinicians need to practice effectively,” says Physicians Committee President, Neal Barnard, MD.

“Given that poor diet is the most significant risk factor for premature death and that food insecurity is dramatically increasing in the United States there has never been a more important moment to advance nutrition and food education for physicians and health professionals. It is imperative to create opportunities to educate health care providers about proper nutrition and food for their patients and the planet, especially those in under-resourced communities that are most affected by COVID-19 and climate change,” says Executive Director of Hunter College NYC Food Policy Center, Charles Platkin, Ph.D., JD, MPH.

The link to the report is available here.

FLPC Releases Two Issue Briefs Proposing State and Local Policies to Increase Physicians’ Nutrition Education in Massachusetts and New York

The Harvard Law School Food Law and Policy Clinic (FLPC) released two issue briefs today identifying state and local policy approaches to increasing the nutrition competency of Massachusetts and New York-trained physicians. These issue briefs, Nutrition Education for Physicians and Health Professionals: Policy Opportunities for Massachusetts and Nutrition Education for Physicians and Health Professionals: Policy Opportunities for New York, map the potential opportunities that the governments of Massachusetts, New York State, and New York City could take to ensure that physicians trained and practicing in their jurisdictions are able to prevent, address, and treat diet-related diseases.

Diet is the most significant risk factor for disability and premature death in the United States. Heart disease, cancer, stroke, and diabetes—all highly correlated to diet—are among the leading causes of death. In the midst of the COVID-19 pandemic, the impact of diet-related diseases has become even more severe, as individuals with diet-related conditions have been especially impacted by the coronavirus. Although many people consider physicians to be a trusted source of information on the prevention and management of diet-related conditions, in actuality most physicians receive little to no formal education on nutrition. Classes on nutrition account for less than one percent of lecture hours offered by U.S. medical schools, and 73% of physicians report that they have received no or minimal instruction on nutrition. As a result, 86% of practicing physicians report feeling unqualified to offer nutritional advice to their patients. This gap in medical education is a glaring missed opportunity to invest in better population health, as doctors who are trained in diet and nutrition are more likely to include nutrition assessments during patient exams, communicate accurate basic nutrition advice, and provide referrals to dieticians as needed.

The issue briefs provide specific policy solutions that can make Massachusetts and New York leaders in the movement to ensure that physicians receive adequate nutrition education. The issue briefs lay out a variety of methods by which policymakers can encourage schools to increase their nutrition education offerings, such as by leveraging funding and financial incentives, offering recognition incentives such as recognition awards, and providing technical assistance. As one example, the New York issue brief recommends that the New York State Department of Health create an incentive structure that gives in-state teaching hospitals higher Medicaid reimbursements if their residency programs have met designated nutrition education-related benchmarks.

In light of the constraints on the healthcare system and state budgets imposed by the COVID-19 pandemic, both issue briefs contain an Executive Summary that highlights the policy recommendations that are most likely to be feasible in the near term. A key recommendation highlighted in the Massachusetts issue brief Executive Summary, for example, suggests that the Massachusetts Board of Registration in Medicine, the state regulatory body that licenses Massachusetts physicians, amend its regulations to create nutrition education requirements as a part of Massachusetts physicians’ continuing medical education (CME) requirements.

The issue briefs build upon FLPC’s September 2019 report, Doctoring Our Diet: Policy Tools to Include Nutrition in U.S. Medical Training. Doctoring Our Diet highlighted the lack of education on diet-related diseases and nutrition that doctors receive over the course of their medical careers and provided recommendations for policymakers to tackle this issue on a nationwide scale. The New York issue brief was prepared at the request of the Office of Brooklyn Borough President Eric Adams, and the Massachusetts issue brief was inspired by conversations about Doctoring Our Diet with the Food is Medicine Massachusetts (FIMMA) Coalition’s Provider Nutrition Education and Referral Task Force, which similarly aims to build capacity to better prepare health professionals in Massachusetts to address questions related to food, diet, and nutrition.

Since 2017, FLPC has collaborated with the Nutrition Education Working Group (a group of medical and public health faculty at Harvard, Northwestern, the Cleveland Clinic, and the Gaples Institute) and partners across the country to raise awareness about the lack of nutrition education provided in medical training by presenting the issue to policymakers, writing comments to the Accreditation Council for Graduate Medical Education (ACGME), and working with various medical boards to add nutrition-focused questions to exams. The issue briefs are the latest effort in FLPC’s ongoing commitment to policy development at the intersection of food and medicine.

 

Harvard Food Law and Policy Clinic Identifies Policies to Improve Nutrition Education for Doctors in Massachusetts

Today, Harvard Law School’s Food Law and Policy Clinic (FLPC) released an issue brief outlining a menu of policy opportunities to systematically improve nutrition education for doctors and health professionals in Massachusetts. Food plays a key role in shaping health outcomes; diet-affected diseases — heart disease, cancer, stroke, and diabetes, among others — are the leading causes of death in the United States. However, health care providers in Massachusetts rarely receive formal education or training on nutrition. Amidst the COVID-19 pandemic, the need for health care providers to support patients’ nutrition needs is further underscored as rates of food insecurity soar and those with both COVID-19 and underlying, diet-affected diseases are at an increased risk of severe illness or death.

Today’s issue brief lists policy solutions to “ensure that physicians trained and practicing in Massachusetts are able to prevent, address, and treat diseases that have a link to diet.” FLPC’s recommendations range from increasing financial or recognition incentives for medical schools offering nutrition programs, to establishing a state office that can provide technical assistance on nutrition programs for health care professionals, to establishing licensure requirements. The opportunities outlined in the issue brief are tailored to Massachusetts, but they build on national recommendations FLPC made in their 2019 report, Doctoring Our Diet.

“We know that diet is often a root cause of poor health outcomes, but our trusted health care professionals are not trained to help,” said Emily Broad Leib, Faculty Director of FLPC and Professor of Law at Harvard Law School. “Massachusetts has a lot of reasons to improve provider nutrition education. For starters, the state’s population is burdened by diet-affected diseases despite the availability of several state-based health and food system innovations. As Massachusetts continues increasing access to nutrition interventions to improve individual and public health, we need our health care providers onboard and able to identify their patients’ food-related needs.”

Many People on Medicaid and Prisoners Still Lack Access to Hepatitis C Treatment

Originally posted on Hep Mag on Sept. 22, 2020. Written by Liz Highleyman.


Some state Medicaid programs and prison systems still restrict treatment based on substance use or stage of liver disease.


People who rely on Medicaid and prisoners in some states are still being denied treatment for hepatitis C because they do not yet have advanced liver disease or because they use alcohol or drugs, according to recent reports.

Over years or decades, chronic hepatitis C virus (HCV) infection can lead to serious liver complications, including cirrhosis, liver cancer and the need for a liver transplant.

Modern direct-acting antiviral (DAA) medications can cure hep C in more than 95% of people who receive treatment. Before the approval of these medications, the standard of care was interferon-based therapy, which usually had to be taken for six months to a year, caused difficult side effects and only cured about half of treated patients.

Because of the challenges of the old therapy, treatment was often restricted to people who had already progressed to advanced liver disease and those who were being managed by a liver disease specialist and was withheld from those who continued to use, or had recently stopped using, alcohol or recreational drugs.

Today, treatment guidelines recommend that all people with acute or chronic HCV infection should receive treatment, except for those who have a short life expectancy for other reasons. Studies have shown high cure rates for people who use drugs and have demonstrated that treatment can be successfully managed by primary care providers. But DAA drugs are expensive, and many people still do not have access to them.

Last month, a group of Medicaid recipients filed a class action lawsuit alleging that the Texas Health and Human Services Commission is restricting coverage of hepatitis C treatment to those who have already developed severe liver damage. The plaintiffs claim that the restriction violates the federal Medicaid Act and is not consistent with current standards of care.

“At the end of the day, Medicaid coverage is supposed to be governed by medical reasons, not fiscal concerns, especially in the circumstances here where there is no other equally effective treatment available,” the group’s lawyer, Kevin Costello of the Center for Health Law and Policy Innovation (CHLPI) at Harvard Law School, said in a statement.

More than half of states still restrict access based on liver disease status, substance use or the type of doctor prescribing treatment, according to the State of Medicaid Access report from CHLPI and the National Viral Hepatitis Roundtable.

Texas is among the most restrictive states—earning a D+ grade in the report—and is one of the few that continue to deny treatment for people who have not yet developed advanced liver disease. Iowa recently removed a disease severity restriction, bringing its grade up from a C to a B-. Some states have loosened their restrictions after similar lawsuits, but legal action is ongoing in several others.

The Texas plaintiffs argue that the cost of DAAs have come down thanks to new competitors, notably AbbVie, offering effective treatment options in a market that was previously dominated by Gilead Sciences.

The lawsuit notes that the wholesale price for DAA treatment has dropped from as high as $94,000 during 2013 to 2014 to as low as $20,000 today. Companies offer deep discounts to state Medicaid programs, but these prices are typically not publicly disclosed. The plaintiffs also argue that curing hep C before a person develops severe liver complications could provide substantial savings in the long run.

In August, CHLPI urged the U.S. Department of Justice (DOJ) to act against discriminatory barriers to hepatitis C treatment in Medicaid programs and correctional health facilities, citing new research showing that treatment restrictions based on alcohol or drug use violate the Americans with Disabilities Act.

According to the August 1 State of Medicaid Access update, 13 states still deny treatment to Medicaid recipients based on their alcohol or drug use.

“Sobriety restrictions effectively feed this communicable disease, and they are especially damaging in the midst of the COVID-19 pandemic that places people with chronic conditions at greater risk and in the middle of the opioid epidemic that is strongly linked to an increase in HCV prevalence,” CHLPI faculty director Robert Greenwald said in a press statement. “Preventing care for patients with HCV who have a history of substance use disorder is illegal. We want to work with the DOJ to remove these harmful restrictions, but we are also committed to pursuing litigation if discrimination persists.”

CHLPI stresses that treating hepatitis C is also an effective form of prevention, as those who are cured can no longer pass on the virus.

“HCV is curable and preventable, and no one deserves to be denied effective treatment,” Greenwald added. “If we are going to stop the spread of HCV infection in the United States, it is critical that we expand access to DAA treatment to all who need it.”

Treatment Access in Prisons

Prison systems are a key battleground for treatment access, as incarcerated people have a high rate of hep C compared with the general population.

In late August, a federal appeals court sided with the Florida Department of Corrections in a class action lawsuit about treatment restrictions.

As the Miami Herald reported, a federal judge in 2019 ordered the state to provide treatment for all prisoners, citing a “long and sordid history of neglecting inmates who have hepatitis C infections.” But an 11th Circuit Court of Appeals panel voted 2–1 to overturn that ruling, saying the state is not obligated to treat inmates with early-stage liver disease.

The majority judges maintained that the Eighth Amendment, which bans cruel and unusual punishment, does not require that prisons offer medical care that is “perfect, the best obtainable, or even very good,” as long as it avoids providing care that is “so grossly incompetent, inadequate, or excessive as to shock the conscience or to be intolerable to fundamental fairness.”

They also ruled that prison officials may take the cost of treatment into account. “Every minute of every day, ordinary Americans forgo or delay beneficial—and even life-altering—medical treatment because it’s just too expensive,” Judge Kevin Newsom wrote. “What a topsy-turvy world it would be if incarcerated inmates were somehow immune from that cold—and sometimes cruel—reality.”

The AIDS Institute, which also advocates for people living with hepatitis C, blasted the ruling.

“This ruling plays games with inmates’ lives,” AIDS Institute manager of hepatitis advocacy Frank Hood said in a press statement. “Liver damage from HCV is irreversible. Not only is treatment the conscionable action to take, it also helps people lead longer, healthier lives; prevents new cases of HCV; and reduces overall medical costs for the state, as untreated HCV can lead to chronic liver disease, liver cancer and death.”

“With the nation in the grip of a global pandemic that has worse outcomes for those living with chronic liver disease, Florida should focus on increasing HCV treatment, not fighting in court to preserve its right to let more people get sick,” added AIDS Institute deputy executive director Rachel Klein.

Click here to learn more about hepatitis C.

The Federal Government is Failing Communities Suffering From Food Insecurity

This article was originally published in The Appeal on September 22, 2020, and was written by Ona Balkus, Food Policy Director at the DC Office of Planning and former FLPC Clinical Fellow. 


Food insecurity is not an acute emergency, but rather a chronic condition for low-income Americans that existed long before the current public health emergency.

At an event in North Carolina last month highlighting a new U.S. Department of Agriculture (USDA) food program, President Donald Trump displayed a flawed, but pervasive, line of thinking that has guided the federal government response to food insecurity during the public health emergency.

The president stated that the COVID-19 pandemic has many left farmers with “no place to send their crops or livestock,” even as “families across the country were in need of groceries.” He continued, “They wanted to eat well. And next year, they’re going to be eating better than ever before because we’re going to have a tremendous year.” This may sound good in theory, but the millions of families who are facing food insecurity will need more than just groceries to get through the next few months.

Food insecurity is not an acute emergency, but rather a chronic condition for low-income Americans that existed long before the current public health emergency. The USDA defines food insecurity as the lack of consistent access to enough food for an active, healthy life. Without meaningful, structural change, this problem will long outlast the COVID-19 pandemic.

At its root, food insecurity is a symptom of poverty and the result of structural racism and a long history of racist policies, such as redlining, that have created a racial wealth gap and disinvestment in majority Black, Latinx, and Indigenous (BIPOC) communities. These communities are much more likely to live in food deserts, a USDA term used to describe predominantly low-income census tracts with limited access to healthy, affordable food options.  Before COVID-19, Black households were twice as likely and Latinx households were 1.5 times as likely to be food insecure as white households. Food insecurity is connected to lower life expectancy and higher rates of diet-related chronic diseases like diabetes and heart disease.

COVID-19 has nearly doubled the rate of food insecurity in the United States, from 11.1 percent to approximately 21.9 percent among adults. And this increase has once again weighed most heavily on communities of color, with food insecurity increasing by twice as much in Black and Latinx households as in white households. COVID-19 has also presented new challenges for access to food. The stay-at-home orders this spring, for example, underscored how decades of racist planning policies have left many low-income communities of color cut off from grocery stores that provide affordable, accessible food options.

The Trump administration could have responded by acknowledging food insecurity as a chronic, long-term problem made worse by the pandemic. By increasing benefits for the Supplemental Nutrition Assistance Program (SNAP) and other forms of direct cash assistance, they could have provided low-income households with the dignity of choice, while supporting the local businesses where these benefits would be spent.

Instead, the USDA rolled out the Farmers to Families Food Box Program, which pays farmers and food distribution companies to build boxes of food and distribute them to non-profit organizations, who then distribute these boxes to individuals in need. This new program has high administrative costs, making it more expensive than direct cash assistance. Farmers to Families has also been criticized for its questionable contracting choicesdelays, and the long lines it has created in communities around the country, often in the summer heat. The program is re-upped every three months, creating uncertainty for grantees and participants. 

The administration has followed a “cross our fingers and hope it’s over soon” approach with other federal nutrition programs as well. The USDA issued waivers to provide flexibility for programs like SNAP, the Special Supplemental Nutrition Assistance Program for Women, Infants, and Children (WIC), and the National School Lunch Program, but only for only a few months at a time. In some cases, they’ve extended waivers so last-minute that state governments and school districts have had to scramble to roll back messaging about changes to the programs. The waiver to provide free school meals to all children, for example, wasn’t extended until the first day of school for many school districts. Although the waivers themselves were essential, this piecemeal approach lacks strategic foresight, has led to countless hours of lost productivity for program administrators, and has caused confusion and decreased participation in programs by the people who need them most.

Treating hunger as an acute emergency, rather than a chronic condition, is hardly unique, but with attention shifted to food insecurity amid the pandemic, we finally have an opportunity to reimagine our response.

wide body of research shows increasing SNAP and other cash benefits helps low-income Americans escape the cycle of poverty. State and local governments should deploy coordinated, wide-reaching enrollment campaigns to ensure all eligible residents benefit from these programs. We should invest in Black, Latinx, and Indigenous owned food retail stores that serve their communities and employ local residents as a way to build wealth and promote career advancement. Food sector workers, many of whom have been on the frontlines of the COVID-19 response, should get a living wage, paid sick leave, health benefits, and overtime.  

Governments at every level should use their purchasing power to contract with BIPOC-owned small businesses and businesses that value their workers. With COVID-19 highlighting the tight link between diet and health and the importance of “food as medicine”, we should invest in programs that empower healthcare providers to conduct food insecurity screenings at routine visits, and to connect those who screen positive to nutritious food. Lastly, we should be supporting BIPOC farmers with land ownership opportunities in order to begin addressing America’s long history of denying and stealing land from these communities.

Recognizing food insecurity as a symptom of larger systemic problems in our food system is the first step to addressing its root causes. COVID-19 has simply thrown this chronic issue into more stark relief. Governments at all levels cannot afford to miss this opportunity to make bold, system-wide reform.

Health Law and COVID-19

On September 16, Harvard Law School’s Colloquium series titled, COVID-19 and the Law: Law and Policy to Address Basic Needs and Marginalized Populations, hosted a discussion on Health Law and COVID-19, featuring Robert Greenwald, Clinical Professor of Law and Faculty Director of the Center for Health Law and Policy Innovation; Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center for HealthLaw Policy, Biotechnology & Bioethics; and Peter Barton Hutt, former FDA Chief Counsel and leading Food and Drug Law scholar. The discussion covered a range of legal questions related to the U.S. health and public health response to COVID-19, including: testing, treatment, and vaccine development and approval; ethical and liability questions related to allocation of medical equipment; questions about disability and age discrimination in treatment and care; and questions of health care access and health equity, among others.

Visit the Colloquium’s website for more information, and watch the recording here:

CAFS Alumni Spotlight: Esther Akwii LLM’20 Heads To Harvard

This article was originally written and published by Vermont Law School on September 16, 2020.


Originally hailing from Uganda, Esther Akwii LLM’20 worked with smallholder farmers and held a position at the Food and Agriculture Organization of the United Nations in Rome, Italy, before coming to Vermont Law School to earn an LLM in Food and Agricultural Law.

As an LLM Fellow at the Center for Agriculture and Food Systems (CAFS), she helped to pilot a range of CAFS projects in partnership with organizations across the U.S. She wrote a background paper on rural development for the Farm Bill Law Enterprise; developed legal memos on farm business structures, agritourism, food safety and labor for Farm Commons; created a brief on rural food access for the Healthy Food Policy Project; and worked on a handbook about policies that promote farm to school programs for the National Farm to School Network. She also taught Law and Policy of Local Food Systems, a course at VLS. 

Akwii applied the knowledge she’d gained through that work by presenting at conferences across the country. “I enjoyed learning and hearing perspectives from farmers or people with lived experiences about food system issues such as access to healthy food,” she said, “and also sharing the work I was undertaking at CAFS and learning from other scholars in the field.” 

Now Akwii will be joining some of those scholars in her new position as a Clinical Fellow at Harvard Law School’s Food Law and Policy Clinic. CAFS partners with the Harvard clinic on several projects, including the Blueprint for a National Food Strategy and the Farm Bill Law Enterprise. Akwii will continue to shape those projects in her new position—as well as the Global Food Donation Policy Atlas—and the CAFS team is thrilled that they will still have a chance to work with her.

“I enjoyed learning and hearing perspectives from farmers or people with lived experiences about food system issues such as access to healthy food.”
— Esther Akwii LLM’20

“Esther is one of the hardest working people I know, excelling in her classes and taking on more work than seemed humanly possible,” said CAFS Director Laurie Beyranevand. “All the while she brought a lot of sunshine into otherwise gloomy Vermont winters and a positivity unmatched by most. While we are reluctant to see her go, we take some solace in knowing she’ll be just a short drive away.”

 

New York Increases Access to Hepatitis C Treatment for Medicaid Patients

Originally published on Hep Mag by NVHR on September 21, 2020.


New York State Medicaid recently removed prior authorization requirements for new hep C patients, increasing opportunities for individuals.


The National Viral Hepatitis Roundtable (NVHR), the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI), and the Treatment Action Group (TAG) today applauded New York State (NYS) Medicaid for removing the requirement that new patients receive prior authorization approval for hepatitis C treatment. Additionally, NYS Medicaid will no longer impose sobriety screening requirements, which will help increase access to hepatitis C treatment for 223,700 individuals living with hepatitis C in New York.

“Removing prior authorization requirements is an important step in expanding access to hepatitis C treatment and we look forward to this policy being equally implemented across payors,” said NVHR Policy Manager Adrienne Simmons, PharmD. “By also eliminating the need for substance use screening, NYS Medicaid is removing discriminatory policies that propagated stigma and contradicted the standard of care.”

Prior authorization is a tool used by payors and insurance companies to determine if they will cover a prescribed procedure, treatment or medicine. In many cases, even if a clinician recommends a patient for hepatitis C treatment, Medicaid payors can deny coverage, which can lead to worse health outcomes for patients.

“Prior authorization requirements put payors in control of prescribing decisions, when clinical providers and patients should be making health care decisions together. Removing prior authorizations for first time treatment with direct acting antivirals for hepatitis C will shorten the time from diagnosis to cure and help New York State fulfill our commitment to ending the deadly hepatitis C epidemic,” said Annette Gaudino, Director of Policy Strategy at the Treatment Action Group.

However, current differences in coverage among fee-for-service and managed care organization programs continue creating barriers to universal access for hepatitis C treatment. With the new policy to remove prior authorization for preferred direct acting antivirals, NYS Medicaid payors have an opportunity to ensure coverage parity across programs. 

“It is encouraging to see New York remove prior authorization requirements for first time hepatitis C treatment patients and help reduce further health complications and liver cancer,” said Robert Greenwald, Clinical Professor of Law at Harvard Law School and the director of CHLPI. “We encourage all payors and providers to immediately implement the new policies to help improve public health outcomes, especially during the coronavirus pandemic.”

For more information about NYS Medicaid hepatitis C treatment requirements, please visit https://stateofhepc.org/report/#NewYork.

New York Increases Access to Hepatitis C Treatment for Medicaid Patients

This article was originally posted on the National Viral Hepatitis Roundtable website on September 21, 2020. 


New York State Medicaid recently removed prior authorization requirements for new patients, increasing opportunities for individuals to be treated and cured of hepatitis C.

The National Viral Hepatitis Roundtable (NVHR), the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI), and the Treatment Action Group (TAG) today applauded New York State (NYS) Medicaid for removing the requirement that new patients receive prior authorization approval for hepatitis C treatment. Additionally, NYS Medicaid will no longer impose sobriety screening requirements, which will help increase access to hepatitis C treatment for 223,700 individuals living with hepatitis C in New York.

“Removing prior authorization requirements is an important step in expanding access to hepatitis C treatment and we look forward to this policy being equally implemented across payors,” said NVHR Policy Manager Adrienne Simmons, PharmD. “By also eliminating the need for substance use screening, NYS Medicaid is removing discriminatory policies that propagated stigma and contradicted the standard of care.”

Prior authorization is a tool used by payors and insurance companies to determine if they will cover a prescribed procedure, treatment or medicine. In many cases, even if a clinician recommends a patient for hepatitis C treatment, Medicaid payors can deny coverage, which can lead to worse health outcomes for patients.

“Prior authorization requirements put payors in control of prescribing decisions, when clinical providers and patients should be making health care decisions together. Removing prior authorizations for first time treatment with direct acting antivirals for hepatitis C will shorten the time from diagnosis to cure and help New York State fulfill our commitment to ending the deadly hepatitis C epidemic,” said Annette Gaudino, Director of Policy Strategy at the Treatment Action Group.

However, current differences in coverage among fee-for-service and managed care organization programs continue creating barriers to universal access for hepatitis C treatment. With the new policy to remove prior authorization for preferred direct acting antivirals, NYS Medicaid payors have an opportunity to ensure coverage parity across programs. 

“It is encouraging to see New York remove prior authorization requirements for first time hepatitis C treatment patients and help reduce further health complications and liver cancer,” said Robert Greenwald, Clinical Professor of Law at Harvard Law School and the director of CHLPI. “We encourage all payors and providers to immediately implement the new policies to help improve public health outcomes, especially during the coronavirus pandemic.”

For more information about NYS Medicaid hepatitis C treatment requirements, please visit https://stateofhepc.org/report/#NewYork.

The law is ‘tested and illuminated during this pandemic’

Originally written by Erin Peterson and published by Harvard Law Today on September 16, 2020.


A colloquium on governmental powers during a pandemic kicks off an ambitious virtual series on COVID-19 and the Law


In the first colloquium of a sweeping new series, “COVID-19 and the Law,” five Harvard Law faculty members grappled with the challenges, limitations, and opportunities of governmental powers during a public health crisis.

The colloquium was the first of 11 sessions focused on COVID-19 topics that will run weekly through mid-November. Other subjects will address areas including health law, elections, education, and access to justice, with a particular emphasis on the urgent needs of marginalized populations, low-income and unemployed Americans, and people of color.

“The pandemic shines a spotlight on the inequities, frailties, and failures, system-wide, in all of our social institutions. That includes legal institutions,” said 300th Anniversary University Professor and moderator Martha Minow, who is co-organizing the series with Clinical Professor of Law Emily Broad Leib ’08, faculty director of the Harvard Law School Food Law and Policy Clinic.

Martha Minow, 300th Anniversary University Professor

Credit: Lorin GrangerMartha Minow, 300th Anniversary University Professor, is co-organizing the “COVID-19 and the Law” series with Clinical Professor Emily Broad Leib ’08, faculty director of the Harvard Law School Food Law and Policy Clinic.

“COVID-19 and the Law” is one of a trio of series being launched this fall by HLS faculty on pressing topics of COVID-19 and ongoing racial discrimination and injustice. The other two series, “Racial Equality?” and “Policing in America,” will begin later this month.

Panelists addressed essential questions about the scope of governmental powers during a pandemic:

Can governments issue and enforce orders that limit individual freedoms in the pursuit of public health?

With stay-at-home orders and mask mandates making front-page news—and protests about their legitimacy doing the same, the tensions between these twin desires is apparent.

Harvard Law Professor Vicki C. Jackson said that there is no single answer that can resolve the conflict. “It’s clear that governments—state, federal, or city—can limit our freedoms in an epidemic,” she said, citing Jacobson v. Massachusetts, a 1905 case that upheld a state requirement for citizens to get a vaccination against smallpox.

At the same time, Jackson added that “these powers are not unlimited,” noting that the Jacobson ruling itself indicated that general rules—such as requiring vaccinations—might not apply if an individual could show that they would be “particularly injured by a requirement.”

As rules get challenged, Jackson said standards of review may vary, but that they should be “sensitive to the underlying evidentiary basis for the decision. What the science says should matter when it’s urged as a basis for restricting rights in a public health crisis.”

How do different levels of the U.S. government work together—or not—during a pandemic?

Our country’s messy federalist system—defined by disaggregated sources of power —has plenty of flaws, said Assistant Professor of Law Nikolas Bowie ’14. Nonetheless, he said, “the pandemic has illustrated many contexts in which that sort of disaggregation is valuable for everybody.”

For example, concentrated power would have allowed for a faster, more robust response to the pandemic. But such concentrated power has a downside. “Bad leadership would be a mortal danger to the entire nation,” he said.

Niko Bowie

Assistant Professor Nikolas Bowie ’14

Instead, during the pandemic, state and local responses—stay-at-home orders and eviction and rent moratoria, for example—offered a way for these smaller government entities to address concerns about pandemic even without a larger federal response.

Still, Bowie noted that there remains a mismatch in power between local, state, and federal governments that will become clearer as time wears on and the economy struggles: only the federal government “has the power to print money, to enter into a deficit, and to power the country through this upcoming recession with stimulus packages and job guarantees.”

How does Europe handle decision making and power during a pandemic?

In Europe, decision-making during a pandemic—with its multiple layers of governance and a patchwork of relevant legal norms—is “a puzzling question,” said Professor of Practice Urs Gasser LL.M. ’03

The top level of decision-making during a pandemic is guided by the World Health Organization’s International Health Regulations, followed by a European layer of laws and regulations that are focused “on supporting and coordinating mechanisms.” Legislation at the national level provides jurisdiction and authority, but significant decision-making is pushed down to state levels, flowing from the subsidiary principle—a key concept across Europe.

The interoperability of these different levels of governance in Europe is not always straightforward, said Gasser, which is not unlike the United States. He argued that the structure worked reasonably well at the higher levels, particularly for sharing information. However, for decisions that get pushed to the state and local levels, “we see fragmentation … of the responses and measures that are taken,” from travel restrictions to decisions on in-person schooling.

In what ways do other professions “fill the gaps” when the government and the law can’t protect everyone?

During the pandemic, nearly every profession responded to the crisis by asking the fundamental questions that drive its field. Those questions helped determine their responses—and in some ways can fill gaps that other fields’ big questions don’t sufficiently address.

For example, said Professor Jonathan Zittrain ’95, “lawyers start by asking questions like … ‘What are the sources of authority by which the government can act to protect everybody?’ ”

By contrast, he said, other professions look at the same situation and ask different questions. Public health professionals ask, “How can [we] protect the common good?” Economists want to know how to support both businesses and people.

Zittrain said the technology community asks, “What sort of gizmos do we have that can make this all go away?” It’s a reasonable question: private industry has built a significant surveillance framework that could be used for contact tracing, provided that privacy concerns could be alleviated.

During the pandemic, why have we (mostly) obeyed the rules?

Compared to the way that it has played out in Europe, the pandemic in the United States has had a particularly strange feature, said Professor Noah Feldman: “extremely little law.”

A series of state orders have formed the rough legal framework for the country’s response to the virus. Yet despite this patchwork of rules, limited enforcement of regulations, and the modest trickle of news stories of people openly defying certain guidelines, citizens have largely obeyed the ordinances that are in place where they live.

Why? Feldman argued that there is something larger than the law or fear of punishment at work. “I think people are listening to the guidance … because they see themselves as part of a collective,” he said. “They’re trying to act more or less responsibly by their own lives under these circumstances.”

Given the level of social and political division in the country, said Feldman, it is remarkable that we are following this “collective unwritten contract.”

As the panelists’ discussion made clear, “law is implicated as both a resource and as a problem,” during a public health crisis, said Minow. There are “many ways in which legal rules and issues, as well as practices and institutions, are tested and illuminated during this pandemic.”

Visit the COVID-19 and the Law Colloquium Series website to learn more about this colloquium and see further resources related to this topic.


Watch the discussion