MassHealth to pay for hepatitis C drugs for all infected members

Originally published by the Boston Globe on June 30, 2016 by Felice Freyer 

The state’s Medicaid program announced Thursday it is lifting restrictions that prevented many patients from getting powerful drugs that can cure hepatitis C, after negotiating new discounts from two manufacturers.

The changes at MassHealth, as the program is known, take effect Aug. 1.

The agreement lowers the cost of three brands of a new class of drugs that are highly effective against the liver-destroying virus — but are also very expensive.

Medicaid programs around the nation have struggled to pay for the drugs, and most states have refused to cover them unless patients already suffered severe liver damage. But court challenges and pressure from advocates and the federal government are starting to turn the tide. Massachusetts is among 10 states, including Connecticut, Maine, and New York, that have lifted restrictions on access to the drugs or are in the process of doing so.

With the restrictions gone, more MassHealth enrollees will get treatment — more than 3,400 expected in the fiscal year that starts Friday. But because of the lower prices they negotiated, state officials said that expenditures on hepatitis C would not increase, holding steady at $200 million for the year.

The move prompted words of praise from Andy Slavitt, acting administrator for the Centers for Medicare & Medicaid Services, which notified Medicaid directors in November that the law required Medicaid to cover the drugs.

“We appreciate the leadership that Governor [Charlie] Baker and the Commonwealth of Massachusetts have demonstrated in taking these actions,” Slavitt’s statement said. “We are pleased by these steps and are eager to work with a number of other states to follow a similar path.”

The decision was also greeted with jubilation among advocates.

“That is fantastic news,” said Dr. Camilla S. Graham, an infectious disease specialist who treats many hepatitis C patients at Beth Israel Deaconess Medical Center, when a reporter told her of the state’s action.

“This is a very big deal for patients in Massachusetts.”

The current system has required her often to tell patients they could not get treatment until their livers were badly damaged.

By that point, even after being cured of the virus, such patients faced a lifelong risk of liver cancer and would need twice-yearly screening tests.

“It was such a terrible thing to have to say to somebody,” Graham said.

Robert Greenwald, director of Harvard Law School’s Center for Health Law and Policy Innovation, said, “This is a great day for low-income people living with” hepatitis C. A suit by Greenwald’s organization against Washington state led to a federal district court decision in May ordering that state to start covering the drugs regardless of the condition of the patient’s liver.

The list prices for the new generation of hepatitis C drugs, known as direct-acting antivirals, range from $54,600 to $94,500 for a 12-week course of treatment, but Medicaid programs and insurers negotiate discounts that are not disclosed. MassHealth recently launched negotiations to wrest even lower prices, which come in the form of rebates.

As a result, MassHealth will cover Harvoni, a drug from Gilead Sciences, for 80 percent of its members who are infected with hepatitis C. About 20 percent of MassHealth members will have access to another Gilead drug, Sovaldi, or to Bristol-Myers Squibb’s drug Daklinza.

Several other drugs in the same class are available, including a new one approved Tuesday. But Graham said that the three drugs covered by MassHealth will cure the vast majority of people with hepatitis C, a virus transmitted through the blood, most often when intravenous drug users share needles.

Marylou Sudders, secretary of the Executive Office of Health and Human Services, said in a statement the goal “is to ensure a sustainable, cost-effective approach to covering MassHealth members who need treatment for hepatitis C infection. . . . We will continue to push drug companies to give us the very best prices on new treatments as they come on the market.”

Currently, about one-third of MassHealth enrollees are eligible for the hepatitis C drugs without restrictions. But the two-thirds who obtain their MassHealth coverage through a private insurer are often denied.

These insurers will pay for the drugs only for patients whose livers are severely damaged, and some also require visits to specialists and evidence of sobriety.

Effective Aug. 1, MassHealth will require the insurers to eliminate those restrictions.

Eric Linzer, spokesman for the Massachusetts Association of Health Plans, said insurers have few details but praised MassHealth’s action as “an important step to rein in the high cost of these drugs.”

MassHealth, which pays for health care for more than 1.85 million low- and moderate-income people and people with disabilities, negotiated the rebates with Gilead after state Attorney General Maura Healey warned the company in January that it faced possible legal action unless it lowered the price of Harvoni and Sovaldi.

The attorney general is trying to get discounts for other sectors of state government that serve thousands of residents but aren’t eligible for the MassHealth rebates.

Her office is negotiating for better prices for the state Office of Pharmacy Services, which purchases medicines for the Department of Corrections, the Department of Public Health, the Department of Mental Health, and state hospitals.

Massachusetts has become a focal point in the growing backlash against soaring prescription drug prices, which can run tens of thousand of dollars a year for mass market medicines and hundreds of thousands a year for rare disease therapies.

In addition to Healey’s efforts with Gilead, state Senator Mark C. Montigny, a New Bedford Democrat, has proposed sweeping provisions to rein in drug prices. And a Boston watchdog group, the Institute for Clinical and Economic Review, is working on frameworks for pricing medicines based on their value to patients.

Here’s How Congress Plans To Save Food From The Trash

Originally published on June 28, 2016 by Casey Williams for Huffington Post.

In Congress these days, it’s all about that waste. 

Legislation introduced Wednesday in the Senate aims to dramatically reduce the amount of food being wasted in the U.S. While it’s not the first bill to tackle the issue, it’s one of the broadest and beefiest.

The Food Recovery Act, sponsored by Sen. Richard Blumenthal (D-Conn.), includes measures to educate consumers about food waste, nudge school cafeterias to buy banged-up fruits and vegetables and simplify expiration dates.

The bill represents a “broad and effective way to prevent waste,” Blumenthal told The Huffington Post. If passed, the law would help “save money, save food for people who are food insecure” and avoid a host of environmental damages, he added. 

The Senate bill is a companion to legislation Rep. Chellie Pingree (D-Maine) introduced in the House of Representatives in December. And it comes just about a month after Blumenthal and Pingree rolled out legislation that seeks to create a new, uniform system for food date labels. 

Up to 40 percent of the nation’s food goes uneaten, yet millions of Americans aren’t able to put healthy meals on their tables. The recent stream of food waste legislation reflects a growing desire among individuals, businesses and legislators to rein in the country’s waste problem, said Emily Broad Leib, director of the Harvard Food Law and Policy Clinic. 

“Food waste is this invisible problem,” she told HuffPost. “I think it’s the kind of thing where once people start talking about it and realize how much food they’re wasting and how much food is wasted nationally, it’s like, ‘This is crazy, we have to do something about it.’”

“I feel like now we’ve reached this tipping point where it’s in the public consciousness,” she added.  

There’s a lot packed into the new bill, but here are some of the highlights.

The proposed legislation would fund campaigns to educate consumers about food waste, as well as promote efforts to teach kids in schools about waste. It would also strengthen good Samaritan laws, which shield businesses that donate old food from lawsuits if recipients of their food get sick, and establish an Office of Food Recovery to oversee the country’s efforts to reduce food waste. 

One of the bill’s more zeitgeisty provisions would encourage schools to buy fruits and veggies that don’t meet high aesthetic standards — so-called “ugly” produce — for their cafeterias. Stocking imperfect fruits and veggies is something anti-waste advocates have been calling on large food retailers, including Walmart, to do as well. 

In addition, the bill includes a provision to standardize date labels on food. The Food Date Labeling Act, introduced in May, also calls for a uniform date labeling system. Both pieces of legislation, if passed, would replace the current confusing and largely unregulated labeling system with just two labels: one indicating a food’s quality (“best if used by”) and one indicating when a food will become unsafe to eat (“expires on”). 

That small change could put a huge dent in the country’s waste problem, according to Blumenthal.

“We will see a drastic change in consumer practice as more people understand that the sell by date has no relevance to food quality or safety and that we can feed more people who now go hungry,” he said.

The Senate bill differs in a few ways from its counterpart in the House, which is currently in committee. The earlier bill included tax incentives for donating uneaten food and several other anti-waste measures. The new Senate bill doesn’t include these provisions because most of them were tucked into the omnibus spending bill that Congress passed in December. 

The Food Recovery Act also doesn’t include much regulation. With the exception of a measure requiring food distributors with government contracts to donate leftover food to food pantries, the bill doesn’t force businesses to take steps to reduce waste.  

“None of it’s really restricting or saying you have a duty to do certain things,” Broad Leib said. “For the most part, it’s not creating restrictions, and I do think it at some point it might be nice to think about ways to have requirements on companies to make better decisions about food waste.”

While there appears to be bipartisan support for measures to reduce food waste, there’s likely to be opposition to at least some aspects of the bill, according to Broad Leib.

“There’s so much in here that there might be people against this little provision or that little provision,” she said. “I would surprised if this whole thing passed in its entirety.” 

I think we have a moment right now with this and with the date labeling act,” she added. “It feels like there’s a real opportunity to make progress and I’m hopeful that we won’t miss this opportunity.”

FLPC Director Quoted in Guardian Story on Food Waste Reduction

A Sunday, June 26, 2016 article from The Guardian asks “Can Walmart’s food labels make a dent in America’s $29bn food waste problem?

Guardian_Walmart storyThe article, written by Twilight Greenaway, looks at Walmart’s efforts to reduce food waste through the use of standardized labels for their private label “Great Value.” All products in the line are required to use the label “best if used by,” which was found to be the best label to indicate a potential change in quality but not food safety after surveying Walmart shoppers.

Emily Broad Leib, director of the Harvard Food Law and Policy Clinic, spoke to The Guardian about the clinic’s long history of raising awareness of the issue of confusing date labels.

“Broad Leib has considered confusing date labels as one of the “biggest components of household food waste” since she was approached by former Trader Joe CEO Doug Rauch four years ago to help him maneuver a series of legal hurdles to start Daily Table, a retail company that specialized in excess or overstocked from grocery stores, food suppliers, manufacturers, restaurants and growers sold at a discounted price.

She would like the government to set clear policies, such as a list of prepared foods – think unpasteurized dairy and deli meats – from the Food and Drug Administration (FDA) and the US Department of Agriculture that do need the “expired on” label. She is already working with federal lawmakers to address the lack of standards for date labeling: a bill introduced by Representative Chellie Pingree (D-Maine) and Senator Richard Blumenthal (D-Connecticut) in May aims to create the same changes that are taking place at Walmart.”

Read “Can Walmart’s food labels make a dent in America’s $29bn food waste problem?” in full.

CHLPI Attends American Diabetes Association 76th Scientific Sessions

ADA Scientific Sessions_speakers

(l-r) Sarah Downer, CHLPI; Dr. Seth Berkowitz, Massachusetts General Hospital; Kim Prendergast, Feeding America; and Kate Hilliard, Food Bank of Corpus Christi.

On June 13, 2016, CHLPI Clinical Instructor Sarah Downer presented to over 100 attendees at the American Diabetes Association’s 76th Scientific Sessions on policy and advocacy tools to address diabetes in low-income populations. In a session titled Improving Diabetes Outcomes in Low-Income Populations: When Food Access is the problem, Sarah joined Massachusetts General Hospital expert in diabetes clinical care Dr. Seth Berkowitz, Feeding America Consulting Project Manager Kim Prendergast, and Nutrition Education Manager of the Food Bank of Corpus Christi Kate Hilliard to discuss the link between diabetes and diet.

Dr. Berkowitz shared the latest research on how food insecurity increases the risk of diabetes and contributes to worse diabetes outcomes. Kim Prendergast described Feeding America’s member food bank partnerships with healthcare providers and the impact of the organization’s innovative diabetes-appropriate food box intervention for individuals with diabetes. Kate Hilliard discussed strategies her food bank uses to reach the underserved populations in Corpus Christi, including individuals who move frequently, do not speak English, and/or do not have health insurance.

Closing the panel, Sarah called on the attendees to be advocates for policy change and champions of using food and nutrition interventions to address diabetes. She outlined  policy priorities including: (1) requiring/incentivizing screening for food insecurity in the clinical setting, (2) developing braided funding streams for healthcare and community-based resource providers to support delivery of enhanced services, (3) increasing research into the impact of different levels of food-based interventions on diabetes, and (4) acting immediately to conduct pilot and demonstration projects within our current public healthcare systems.

Attendees were enthusiastic about pursuing opportunities to expand access to medically-tailored food to their patients, who face numerous health and resource challenges and often must make terrible choices between paying for medication or buying food.

CHLPI Presents at Food is Medicine Forum

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Clinical Instructor Sarah Downer recently presented CHLPI’s cutting edge food and healthcare advocacy work to over 400 attendees of the Food is Medicine Forum in Bangor, Maine.

The Forum, sponsored by Eastern Maine Healthcare Systems, brought together experts in food policy and leaders of innovative, solution-driven nonprofits from across the country to explore ways to address the high rate of food insecurity in Maine. Kristen Miale, of the Good Shepherd Food Bank in Auburn, Maine, explained that a high cost of living contributes to making 16% of Mainers food insecure, meaning that they lack access to enough food to live an active, healthy life.

Researchers from the University of Illinois, Children’s Healthwatch, and the CDC spoke about the negative health consequences associated with food insecurity and the importance of linking the healthcare system more closely to community-based resource providers, such as food pantries and meal delivery programs.

CHLPI’s Sarah Downer advocated for the healthcare system to play a more active role in addressing food insecurity in patients with known health conditions and health challenges, describing the significant costs to the healthcare system of food insecurity and pushing for the inclusion of evidence-based food and nutrition interventions that have been shown to improve health outcomes and lower healthcare expenditures. She urged Eastern Maine Healthcare Systems to become a champion of using food as medicine for vulnerable patients and called on the company to introduce a food and nutrition intervention pilot in one of its network hospitals. EMHS, with funding from a CDC Partnership to Improve Community Health (PICH) grant, will continue to actively explore ways that community-based organizations can become stronger partners in supporting patient health.

CHLPI to Host Capstone Discussion for PATHS

PATHS_2016 report coverThe Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School will host Envisioning the Future of Type 2 Diabetes Policy: A PATHS Capstone Discussion in Washington, D.C. on Monday, June 20, 2016. The capstone discussion will bring together experts to shape and drive CHLPI’s next steps to advance a diabetes policy agenda. The goal of this event is to focus CHLPI’s work and its partners’ work on the most promising strategies for improving nationwide health outcomes and addressing health disparities for people at risk for or living with type 2 diabetes.

Since 2012, CHLPI has worked in close partnership with numerous stakeholders to lead diabetes policy work at the local, state, and federal level as part of its Providing Access to Healthy Solutions (PATHS) initiative. By providing technical assistance and advocacy support to community-based advocates and providers and publishing research reports and hosting events for diabetes stakeholders, CHLPI has helped to identify and address gaps in diabetes services, promote opportunities for structural and systemic diabetes law and policy reforms, and establish stronger partnerships. Since the start of the PATHS initiative, CHLPI has seen tremendous success and promising movement in crucial areas of diabetes policy, such as the U.S. Department of Health and Human Services’ 2016 announcement of its intention to provide Medicare coverage for the National Diabetes Prevention Program and the integration of food and nutrition services in Medicaid Managed Care and dual demonstration programs across the country.

The capstone discussion builds off of CHLPI’s PATHS initiative by assessing its accomplishments while looking toward next steps and the future of diabetes law and policy advocacy work. At the event, attendees will discuss key opportunities in the current policy landscape, including: strategies that have been most successful in moving the needle in critical areas in diabetes prevention and management; how to engage stakeholders who could play a larger role in the diabetes dialogue; areas where initial progress can be leveraged to drive broader change; and opportunities for ongoing collaboration and partnerships.

Also during the capstone discussion, CHLPI will release Beating Type 2 Diabetes: Best Practices for States, a report that outlines key policies and practices for states that want to improve access to preventive services, care, and treatment for type 2 diabetes.

Read Beating Type 2 Diabetes: Best Practices for States.
Read the executive summary of Beating Type 2 Diabetes: Best Practices for States.
Download the press release for the capstone and report release. 

FLPC Director Appears on CBS This Morning to Discuss Date Labels

EBL_CBS_Date Labels

On Wednesday, June 8, 2016, Emily Broad Leib, Director of the Harvard Food Law and Policy Clinic, joined the hosts of CBS’ morning show This Morning for a segment on food safety and date labels. She discussed consumer confusion around the variety of existing labels and how the proposed legislation to standardize date label language will simplify the system for both consumers and manufacturers.

Watch the clip of Emily Broad Leib on This Morning online.

CHLPI Faculty Director Quoted in Boston Globe Article on HCV

“After insurer changed policy, he’s winning hepatitis C fight,” is the latest in a series of stories created by Boston Globe reporter Felice Freyer on the tension between Massachusetts residents infected with Hepatitis C and insurance providers in the state with policies denying access to medically necessary medications.

The article, published Tuesday, June 7, 2016, provides an update on John Tortelli, who recently began treatment for his HCV after Tufts Health Plan changed their policy on HCV medications.

Read the full article “”After insurer changed policy, he’s winning hepatitis C fight.”

In Face of Class Action Lawsuit, Delaware Medicaid Removes Unlawful Restrictions to the Cure for the Hepatitis C Virus

After weeks of negotiation arising from a formal threat of litigation, officials at the Delaware Department of Health and Human Services and its Division of Medicaid and Medical Assistance (DMMA) have changed their policy on rationing coverage of life-saving drugs to cure Hepatitis C virus (HCV). On March 28, 2016, attorneys from Community Legal Aid Society, Inc. of  Delaware, in conjunction with Tycko & Zavareei LLP, and the Center for Health Law and Policy Innovation at Harvard Law School sent a formal demand letter to Delaware officials on behalf of their client, Valerie Green, a Delaware Medicaid recipient. The demand letter notified DMMA officials that unless it immediately agreed to remove categorical coverage exclusions of HCV cures from its Medicaid policy, Delaware would face a federal class action lawsuit. On Friday, June 3, 2016, DMMA officials issued a policy revoking these categorical exclusions, effective immediately.

The state’s concession represents a substantial win for Delaware’s Medicaid population.  “DMMA’s new approach is a sea-change in policy that will directly improve the lives of many of our clients—some of Delaware’s most vulnerable citizens. To the extent that DMMA is now focusing on the individual health circumstances of each person whose doctor has prescribed these medications, Delaware’s approach will now be consistent with the law and with many other states around the country,” said Laura Waterland of CLASI. Valerie Green adds “the weight of the world has been lifted off my shoulders. Now I’m excited about my future. I know that everyone else who’s in my position feels the same way. It’s like getting a new lease on life.”

HCV is a communicable disease that causes chronic inflammation throughout the body and can lead to serious liver damage and infections, liver cancer, and death. At least 20,000 people in the United States die each year due to liver disease caused by HCV, making it the most deadly communicable disease in the United States. Even before the advanced state of the disease, individuals with HCV can suffer from diabetes, lymphoma, fatigue, joint pain, depression, myalgias, arthritis and jaundice.

In 2011, the United States Food and Drug Administration (FDA) began approving Direct Acting Antiviral (DAAs) drugs to treat HCV, and in 2014 the FDA approved ledipasvir-sofosbuvir to effectively cure the disease. Treatment guidelines approved by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America confirm that DAAs should be available for “all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy.” See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last visited 6/6/16). For its part, the federal Centers for Medicare and Medicaid Services issued guidance in November 2015 warning states that exclusions and limitations on public insurance coverage of DAAs may violate federal law.

Prior to last week’s change, DMMA restricted Medicaid coverage for the HCV cure only to those whose disease had progressed to the point of significant liver damage or cirrhosis. This was flatly inconsistent with the clinical standard of care noted above.

Anna Haac of the law firm Tycko & Zavareei LLP says, “it is unimaginable that an insurance provider would tell someone with cancer ‘We need to wait until you get really sick before we treat you.’ But that’s what patients in Delaware with HCV were being told, and what patients in other states are still being told. It’s unconscionable. Lawyers and advocates have been waiting for Delaware to live up to its promise to Medicaid patients. It is unfortunate that it took the threat of a federal class action suit, but ultimately I’m glad to see that Medicaid enrollees will no longer be barred from needed medicines.”

By making this policy change voluntarily, Delaware joins a rapidly growing list of states that have come into compliance with federal medical necessity requirements for Medicaid. On May 17, 2016, Pennsylvania’s Pharmacy & Therapeutics Committee voted to recommend the removal of all disease severity restrictions for Hepatitis C treatment from the state’s Medicaid policy. Florida Medicaid took a similar step last week. And on May 27, 2016, a federal judge ordered the state of Washington to strike its Medicaid policy imposing similar coverage exclusions. “Delaware has taken an important first step here,” said Kevin Costello, Director of Litigation at the Center for Health Law and Policy Innovation at Harvard Law School. “But enforcement remains key to make sure that the policy is made meaningful. This change is not only the right thing to do from a public health and legal point of view, but it also been proven that this policy will be cost-effective for the state in the long run. And it goes without saying that the real potential of this cure is the eradication of HCV altogether, a goal that is furthered by early treatment of Medicaid beneficiaries that makes, in their case, further transmission of the virus impossible.”

Read the demand letter filed by Community Legal Aid Society, Inc. of  Delaware, Tycko & Zavareei LLP, and CHLPI.

Read the Delaware Division of Medicaid and Medical Assistance updated policy on HCV medications.

View media coverage of the Delaware decision: