Massachusetts Criminal Justice Reform and Public Health: Part 2, Drug Crimes and Mandatory Minimum Sentences

By Elisabeth J. Ryan

In April 2018, Massachusetts Governor Charlie Baker signed a major criminal justice reform bill, the result of years of efforts by legislators and advocates to implement changes to many existing “tough-on-crime” laws. The bill, at more than 120 pages, contains a plethora of changes, including raising the minimum age for juvenile justice involvement from 7 to 12, restricting the use of solitary confinement, and eliminating mandatory minimums from most drug crimes except for trafficking. However, the bill also creates new crimes, like trafficking in carfentanil.

PHLW will be looking at various provisions of the bill and how they intersect with public health. In Part 1, we looked at the creation of “medical parole” in the Commonwealth. In today’s Part 2, we look at drug crimes and mandatory minimum sentences.

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One of the earlier versions of this reform bill contained a provision that would have allowed people with opioid use disorders to have access to medication assisted treatments (MAT) while in prison. That would have been a major public health triumph, as illustrated by its success in Rhode Island prisons. MAT remains the gold standard of care for opioid use disorders; studies show that people on MAT are more than twice as likely to remain opioid-free. Incarcerated individuals have much higher than usual rates of substance use disorders and are 129 times more likely to die of an overdose within two weeks of release from prison, compared to the general population.  The Rhode Island program that gave its incarcerated population access to MAT not only resulted in much higher rates of adherence to treatment after release, but also corresponded with a 12% reduction in overdose deaths statewide. Unfortunately for Massachusetts, which has one of the highest overdose death rates in the country, the provision that would have provided MAT is prisons did not make it to the final criminal justice bill. Instead, the bill takes a split approach to drug crimes – it reduces the reach of “school zone violations,” shores up “Good Samaritan” laws, and eliminates some mandatory minimum sentences, but it also creates a new trafficking crime with a new mandatory minimum sentence, which is what this part of our series focuses on.

While mandatory minimums have existed in the United States for serious crimes since the 18th century, Congress expanded them to drug crimes in 1986 as part of the “tough on crime” and “war on drugs” era. The Anti-Drug Abuse Act of 1986 created especially harsh penalties for offenses involving of crack cocaine, which resulted “disproportionately harsh prison sentences for defendants who are disproportionately black.” Massachusetts, like many other states, passed similar mandatory minimum sentences for drug crimes in the 1980s, which resulted in similar disproportionate impacts on communities of color.

Almost thirty years after first instituting mandatory minimum sentences for drug crimes, Massachusetts began to scale them back in 2012 with an Act Relative to Sentencing and Improving Law Enforcement Tools. However, instead of actually getting rid of any minimum mandatory sentences as then-Governor Deval Patrick had aimed for, that law only reduced the length of some sentences. While the most recent criminal justice reform bill certainly did not abolish mandatory minimum sentences for drug offenses, it did eliminate them for distribution of Class B (most commonly cocaine) and Class C substances (which includes many prescription narcotics, such as Valium and Vicodin). The bill, however, leaves mandatory minimums in place for trafficking in all classes of drugs.

Notably, the law actually creates new mandatory minimums specifically applicable to trafficking in fentanyl and carfentanil. While fentanyl was added to the list of Class A substances in 2016, this new bill also adds carfentanil to that list. Fentanyl already had a separate trafficking (over 10 grams) sentencing scheme, with a maximum of 20 years imprisonment but no mandatory minimum. This was in contrast to the trafficking sentencing scheme for other Class A drugs, which had mandatory minimum sentences ranging from 3.5 to 12 years, depending on the amount of substance at issue. The new bill adds a mandatory minimum of 3.5 years to trafficking in fentanyl or carfentanil, and though it does not distinguish levels of amounts, the new law allows charges based on whether any mixture of substances weighing 10 grams or more tests positive for fentanyl. Law enforcement had pushed for this change to make charging easier, as fentanyl is rarely found “pure”; instead, it is found mixed with other drugs such as heroin.  This could be seen as simply an adjustment to bring the punishment for fentanyl/carfentanil in line with those for analogous drugs. But it also highlights the particular alarm that these two synthetic opioid drugs in particular have caused in the country’s current “opioid crisis,” some of which is warranted and some of which is not.

The law’s elimination of some mandatory minimum sentences for certain drug crimes while keeping others in place and even creating new ones illustrates the ongoing tension between treating drug use as both a crime and a public health issue. It also reinforces an imaginary line between those who use drugs (increasingly viewed as people with a health or medical condition) and those who sell drugs (viewed as the evil drivers of the opioid crisis). Governor Baker in particular has sought to increase punishment for “dealers.” Last December, he introduced a bill that would have created a new crime of manslaughter for anyone who “manufactures, distributes, or dispenses" any controlled substance if "a death...results from the injection, inhalation, or ingestion of that substance." While his particular bill has not moved far in the legislature, this notion of treating the “sellers” as responsible for overdose deaths has gained traction across the country. One major problem, however, is that most of the people being prosecuted are not the high-level, kingpin dealers that the political rhetoric targets. Instead, they are the friends, significant others, and acquaintances of the decedents who almost always suffer from opioid use disorder as well.

Easing the punishment for some drug crimes while strengthening the punishment for others reflects a “two steps forward, one step back” approach to drug crime in the Commonwealth. Whether such changes will have an impact on incarceration rates and/or opioid overdose deaths remains to be seen.

Massachusetts Criminal Justice Reform and Public Health: Part 1, Medical Parole

By Elisabeth J. Ryan

In April 2018, Massachusetts Governor Charlie Baker signed a major criminal justice reform bill, the result of years of efforts by legislators and advocates to implement changes to many existing “tough-on-crime” laws. The bill, at more than 120 pages, contains a plethora of changes, including raising the minimum age for juvenile justice involvement from 7 to 12, restricting the use of solitary confinement, and eliminating mandatory minimums from most drug crimes except for trafficking. However, the bill also creates new crimes, like trafficking in fentanyl and carfentanil.

PHLW will be looking at various provisions of the bill and how they intersect with public health. First, we look at the creation of “medical parole” in the Commonwealth.

While Massachusetts has the third lowest incarceration rate in the United States, the United States still incarcerates people at a rate higher than any other developed country. Though incarceration has recently dipped, there are still 2.2 million people in prisons and jails in the U.S., compared to half a million in 1980. The United States also incarcerates 655 people for every 100,000 in its population; El Salvador, the country with the next highest rate of incarceration, jails 614 per 100,000, almost 7% less than the U.S. Massachusetts incarcerates 188 people per 100,000, which some state lawmakers claim just makes the Commonwealth the “best of the worst.” Massachusetts voters have expressed a “strong desire to shift the aim of the criminal justice system away from punishing crime and more towards preventing it in the first place, in part by rehabilitating offenders so they do not offend.”

The corrections system and public health have long overlapped. Incarcerated individuals are disproportionately likely to have come from poverty, which is in turn disproportionately likely to be correlated with poor health. People incarcerated in the United States have higher rates of diabetes, hypertension, asthma, and HIV than the general U.S. population.  Incarcerated people also have higher rates of viral infections, substance use disorder, and mental illness. Prison conditions like solitary confinement (which we will address in an upcoming post), violence, and lack of social ties can all contribute to worsening health.

Massachusetts has one of the oldest incarcerated populations in the country, with 17% of inmates being age 55 or higher, compared to a national average of 11%. The population of older prisoners will continue to grow across the country, with an estimated one-third of the entire incarcerated population over the age of 55 by 2030. Studies have shown that incarcerated individuals often have “an accelerated aging process” of 10-15 years, which contributes to higher rates of medical issues than non-incarcerated people of the same age. Aging inmates are at much higher risk for “hypertension, asthma, arthritis, cancer, hepatitis… [and] congestive heart and liver failure.”

Before this recent criminal justice overhaul, Massachusetts was one of the very few states that did not have any form of statutory “compassionate release.” Also called “medical parole,” this is “a correctional policy intended to benefit prisoners with chronic health conditions by releasing them to parole before their expected parole date. The granting of medical parole…is largely based on the severity of disease, the capacity of the prison medical clinic to treat the disease, and the cost implications of continued incarceration.” These policies are also, of course, intended to save money for the system. The corrections system bears the entire cost of medical treatment for its inmates; systems cannot bill Medicare, Medicaid, or private insurance for any care provided to incarcerated individuals. Medical parole would significantly relieve the corrections system of the extraordinary costs of caring for incarcerated individuals with terminal illnesses. Caring for inmates over age 55 and/or those with terminal and incapacitating illnesses can be 2-3 times more expensive than the “average” cost of housing an inmate; Massachusetts spends about $64,000 per year for an “average” person held in maximum security, but it spends almost $284,000 for a “sick” inmate.

The Massachusetts law (section 97 of An Act Relative to Criminal Justice Reform) will allow incarcerated individuals diagnosed with a terminal illness - defined as an incurable condition that will likely cause death within 18 months - or those with “permanent incapacitation” to request medical release before the end of their sentences. Ultimately, the decision is left to the commissioner of corrections or to the appropriate sheriff, who determines whether “the prisoner will live and remain at liberty without violating the law and that the release will not be incompatible with the welfare of society.” How those in power will interpret that clause remains to be seen.

Each potential candidate must have a “medical parole plan,” including a proposed course of treatment, documentation from prospective medical providers, and evidence of a financial plan to pay for the treatment; the statute does not make clear who is responsible for compiling this information. In all cases, the appropriate district attorney will be notified of the impending release and in some cases, the DA or a victim/family of a victim is permitted to request a hearing to oppose medical parole. If granted release, the patient remains under the supervision of the parole board, which can revoke the parole not only based on standard violations, but also if the individual’s illness has “improved” to the point of no longer being terminal or permanent. The released individual would then be required to return to incarceration.

Even though Massachusetts was one of the last states to implement a medical parole program, Governor Baker has already filed legislation trying to scale it back by disqualifying any inmates serving sentences for first degree murder or those who have been adjudicated as sexually dangerous persons. A recent hearing on the bill demonstrated strong opposition to those changes from advocacy groups.

“Medical parole epitomizes the public health approach in that it encourages equal access to health promotion and wellness programs, directly addresses human rights, targets vulnerable populations, and values cost effectiveness.” Yet medical parole has had varying success in other jurisdictions. The equivalent federal program has been “poorly managed and implemented inconsistently,” according to the Department of Justice. In the federal system, prisoners must be completely disabled or have less than 18 months to live to qualify for compassionate releases. Yet federal officials “deny or delay the vast majority of requests,” including one by a 94-year-old inmate serving time for drug crimes, which officials deemed “too serious” for release. Federal officials approved only 6% of 5400 medical parole applications from 2013-17. The Bureau of Prisons currently averages six months to reach a final decision; 266 inmates died from 2013-17 while awaiting decisions. Frustrated by the failure to grant medical releases, Hawaii Senator Brian Schatz has introduced the “GRACE Act,” or “Granting Release and Compassion Effectively,” which would allow an inmate whose request had been denied by the federal Bureau of Prisons to appeal the decision directly to the court system.

After New York expanded its medical parole system in 2009, the policy change “had minimal effect,” attributed by some to the fear that released inmates – even those sick enough to qualify for medical parole – will go on to commit more crimes. In 2014, the NY board granted medical parole to only 17 petitioners.

By adopting medical parole, Massachusetts has taken a step in the right direction, both on criminal justice and public health grounds. The real test will be in how many qualified inmates are released after the new law takes effect.

Policy Pathways to Address Provider Workforce Barriers to Buprenorphine Treatment [from American Journal of Preventive Medicine]

George Consortium member Rebecca L. Haffajee has a new article in the American Journal of Preventive Medicine focusing on some of the reasons why only 40% of people with opioid use disorder actually receive medication-assisted treatment. One major reason is that so few physicians are licensed to even prescribe buprenorphine (such as Suboxone). As the article details, numerous workplace barriers contribute to this lack of licensing, including insufficient training, lack of peer support, inadequate reimbursement, and regulatory hurdles. 

For complete article with footnotes, please see:  https://www.sciencedirect.com/science/article/pii/S0749379718300746

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Introduction

Opioid misuse and overdose continue to escalate, contributing to the growing population with opioid use disorders (OUDs) in need of treatment. The opioid-related overdose death rate increased from 6.1 to 16.3 deaths per 100,000 people from 1999 to 2015, totaling 33,091 deaths in the U.S. in 2015. Rates of opioid-related substance use treatment admissions have followed a similar trajectory. Despite recent abatements in prescription opioid dispensing and use,4 prescribing contributes heavily to those who are misusing opioids.  Moreover, overdoses and infectious diseases resulting from opioid injection drug use continue to climb, and are increasingly attributed to heroin and potent synthetic opioids, such as fentanyl.

Meeting the clinical criteria for an OUD—or a “problematic pattern of opioid use leading to clinically significant impairments or distress,”—increases a person’s risk of early death (typically from overdose, trauma, suicide, or infectious disease transmission) by a factor of 20.The prevalence of OUDs has increased significantly over time, from approximately 1.5 million in 2003 to more than 2.3 million in 2015. Despite the risks of untreated OUD, the gap between OUD prevalence and evidence-based medication-assisted treatment (MAT) capacity was close to 1 million in 2012.

Buprenorphine, one of three medications used as part of MAT, has high potential to address the persistent OUD treatment gap. Buprenorphine is approved for use in non-specialty outpatient settings, has demonstrated effectiveness at promoting abstinence and reducing opioid-related overdoses, and is cost effective. However, according to the Substance Abuse and Mental Health Services Administration (SAMHSA), less than 4% of licensed physicians were approved to prescribe buprenorphine in 2017. In 2016, overall 47% of counties—and 72% of rural counties—lacked a buprenorphine-waivered physician.26 Although buprenorphine capacity has increased since 2002—when it was first approved for OUD treatment in office-based settings—the treatment gap has not significantly narrowed because of the increasing population with OUDs. Moreover, many buprenorphine-approved prescribers treat far fewer than the number of patients allowed by regulations.17; 27 ;  28 Estimates range, but suggest that only 20%–40% of people with OUDs are receiving MAT.

Despite some recent policy successes in expanding buprenorphine treatment insurance coverage, funding, and provider capacity, significant provider and policy barriers remain and must be addressed to capitalize on this promising treatment at a time of dire public health need. This article provides a brief history of MAT and the factors contributing to buprenorphine’s promise. It then outlines persistent provider workforce barriers to buprenorphine provision in the U.S. and policy recommendations to address them.

The rest of the article (including footnotes) is available here: Policy Pathways to Address Provider Workforce Barriers to Buprenorphine Treatment

It's Time for Uncomfortable Solutions to the Opioid Epidemic [from The Fix]

We are thrilled to present some work from brand new George Consortium member Abraham Gutman! This piece from The Fix discusses the fact that we need to get creative, and uncomfortable, in addressing the opioid crisis. Be sure to follow Av's great Twitter feed at @abgutman.

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The results of the War on Drugs: an America that is the most incarcerated nation in the world, a sharp decrease in the price of heroin, and a new Jim Crow for Black communities.

Not every problem has a solution that we are comfortable with. The opioid epidemic and the overdose crisis are two examples of such problems. There has been a lot of work by states and cities to tackle the epidemic and mitigate harm. Laws limiting opioid prescriptions have been enacted (controversially), DEA regulations on who can administer treatment were laxed, Prescription Drug Monitoring Programs were founded, and states of emergency were declared.

“The United States has seen a vigorous legislative response to the opioid epidemic,” writes Scott Burris, the Director of the Center for Public Health Law Research at Temple University, in a recent article, “but legislators are running out of easy targets as the most popular ideas are adopted in all the states.

With no more low-hanging fruits left on the tree, and with the epidemic still raging, it is time to confront the solutions that we are less comfortable with. Philadelphia found itself in the middle of this conversation after city officials announced that they would encourage private organizations to operate comprehensive-user engagement sites, commonly known as safe-consumption sites.

While Philadelphia is the first city in which officials gave their blessing to open a safe-consumption site, other cities—including Denver, Seattle, and New York—are currently considering opening such sites. Two weeks after Philadelphia’s announcement, San-Francisco announced that the city is expecting to be the first city with a site coming July 1st of this year.

Safe-consumption sites are a harm reduction measure that has been shown to enhance access to primary health care for people who use drugs, reduce overdose mortality, and reduce transmission of disease such as HIV/AIDS. The evidence further suggests that the sites reduce the level of public consumption of drugs and dropped syringes without causing an increase in drug use, drug trafficking or crime in the vicinity of the site. Last summer the American Medical Association voted to support the development of pilot safe consumption facilities.

The debate about safe-consumption sites is mostly not about the evidence that supports the efficacy of the practice but about whether it is the right path to take. One opponent in Philadelphia wrote, “we don’t need to enable drug addiction. We need to keep kids off drugs in the first place. We need to help addicts who want to stop using.”

The truth is: we don’t know how keep kids off drugs in the first place. Furthermore, medication assisted treatment, the gold standard treatment for opioid use disorder, is heavily regulated on the state and federal level leading to barriers in access.

America spent billions of dollars in an attempt to convince the nation’s youth to “just say no” to drugs. The phrase that was first used by First Lady Nancy Reagan to respond to an elementary school girl in Oakland in 1982 became a national and international campaign, and a myth. Telling kids to “just say no” doesn’t work. In fact, it might have the exact opposite effect.

If we can’t make kids say no, maybe we can prevent anyone from offering them drug in the first place. This was the logic of Donald Trump in his first State of the Union when he declared that “we must get much tougher on drug dealers and pushers” and that “open borders have allowed drugs” to enter the country. In a recent speech in New Hampshire, Trump doubled down on this line of thinking and called for the death penalty for some dealers.

Getting tough on drugs is in no way a new idea, in fact it is almost 100 years old. America conducted a horrifying policy experiment to see if this idea works. This experiment, known as the War on Drugs, was conducted with communities of color as the subjects. The results are an America that is the most incarcerated nation in the world, a sharp decrease in the price of heroin with virtually no change in the number of high school seniors using illicit drugs, and a new Jim Crow for Black communities. Renewed calls to get tough on crime are either driven by blindness to the realities of the War on Drugs, racism, or a combination of both.

Tightening the border is not doing much to prevent drug abuse either. While Trump believes that a wall will prevent drugs from entering the US, most drugs that cross the southern border do so through legal entry ports to the U.S., according to the Drug Enforcement Administration. In fact, some argue that the tightened border security gave rise to proliferation of Fentanyl, a deadly synthetic opioid much stronger than heroin, because drug traffickers can make profits from very small volumes. Executing drug dealers as a means to reduce the supply of illicit drugs is dehumanizing and racist, unconstitutional, and won't work.

If we can’t completely stop illicit drug use, we can at least provide easily accessible treatment. When it comes to opioid use disorder we even have effective treatment to offer: medication-assisted treatment using methadone, buprenorphine, and naltrexone. But access to medication-assisted treatment is far from sufficient to meet the growing need, with some in rural areas having no providers within a 350 mile radius. Investing in treatment is extremely important, however stigma and regulatory barriers from federal law and DEA regulations make increasing access very difficult.

The fight over increasing access to medication assisted treatment is a worthy and necessary fight that we should engage in with full force. That said, we need to be realistic about how long it will take to change established laws, regulations, and hearts and minds. Meanwhile people who use drugs are actively dying from overdose, suffering from injection related wounds, and contracting bloodborne diseases such as Hepatitis B and C and HIV/AIDS.

Safe-consumption sites are in no way a silver bullet that will defeat the opioid epidemic. They are a strong tool that should be utilized to end the overdose crisis. More than 64,000 Americans died in 2016 from drug overdose. Not taking action on evidence-based practices because the solution doesn't feel intuitive should not be an option.

Some still view safe-consumption sites as “enabling” drug use (even though that is not supported by the evidence). “If the current epidemic can teach us anything, it’s that drug use is soaring unassisted,” writes Dr. Sarah Wakeman, the Medical Director of the Substance Use Disorder Initiative at Mass General Hospital. “The time has come to think instead about how we can enable people to stay alive.”

The effort to end the opioid epidemic is a marathon and not a sprint. As a society our goal must be to ensure that as many people who are currently using drugs cross the finish line with us - alive and with the least irreversible damage. The next steps to do that might go against many of our gut instincts but at the end of the day we must trust the evidence and embrace harm reduction measures.

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The original article can be found here. 

New Dangers For Immigrants and the Health Care System [from Health Affairs Blog]

PHLW's Wendy E. Parmet and Elisabeth J. Ryan co-authored an article posted on the Health Affairs Blog about the potential changes to the definition of "public charge" and how that will negatively impact health care and the health care system. 

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New Dangers For Immigrants And The Health Care System

By Wendy E. Parmet and Elisabeth Ryan

The Trump administration’s crackdown on immigrants may soon create new perils for the health care system if a set of proposed regulations by the Department of Homeland Security (DHS), leaked last month to the Washington Post, are promulgated. The regulations would dramatically expand the definition of “public charge,” a criteria used in immigration law to determine both admissibility to and deportability from the United States. As a result, many immigrants, including many low wage health care workers, may be deterred from using publicly-funded health care benefits to which they and their dependents, including their citizen children, are legally entitled.

The Immigration and Nationalization Act requires most non-nationals (other than refugees, asylees, and certain other protected classes) who seek a visa to show that they are not likely to become a “public charge,” that is, someone dependent on public benefits. Once they are in the United States, most immigrants must make a similar showing if they seek a change in status, for example, if they apply for a green card. In limited circumstances, even green card holders may be deported for becoming a public charge.

An Expanded Definition Of ‘Public Charge’

Under long-standing policy, the use of publicly funded health care benefits (other than long term care) did not render an immigrant a public charge. In January however, the State Department issued a revised Foreign Affairs Manual, used by the consular offices in reviewing visa requests, which expanded the definition of public charge to include consideration of health benefits. The proposed DHS regulations would apply that approach within the United States, treating the use of Medicaid, the Children’s Health Insurance Program (CHIP), the Affordable Care Act (ACA) subsidies, and even benefits wholly funded by the states—but not Medicare—as a factor in determining whether an immigrant had been or would become a public charge. An immigrant could also be found to be a public charge if his or her dependents, including citizen children, used Medicaid or CHIP.

The implications of this potential change for patient care are significant. Non-citizen immigrants are already far less likely than citizens to have health insurance. In part, this is due to the fact that undocumented immigrants are ineligible to participate in the ACA’s exchanges or to receive federally funded health insurance (except for emergency Medicaid). Current law also denies most lawfully present immigrants from receiving Medicaid or CHIP for the first five years they have that status. With less access to insurance, it’s not surprising that immigrants are less likely than citizens to have a usual source of care, or preventive services.

Since the Trump administration took office, there have been widespread anecdotal reports that many immigrants have stopped showing up for their medical appointments. Undoubtedly some of this is due to the general climate of fear created by enhanced enforcement actions, which is especially frightening to those who are undocumented, as well as their families. But advocates also believe that a draft leaked in February 2017 of a proposed executive order expanding the definition of public charge led many immigrants to stay away from the health care system. In response, advocates and providers have tried to reassure immigrants that they should continue getting needed care.

Potential Consequences

If enacted, the proposed regulations will undermine that message, causing more immigrants to forgo needed care, meaning that easily treatable health conditions will go untreated until they become worse, and pregnant women will lack prenatal care. In addition, with immigrants afraid to access coverage for which they are eligible, hospitals and other safety net providers will be forced to bear more unreimbursed costs. The regulations may also create troubling new tensions between immigrant patients and their providers. For example, consider the possible predicament of a legal immigrant who gives birth to a child who needs neo-natal intensive care. By virtue of her birth, the child would be an American citizen and eligible for Medicaid, even if the mother was not eligible, as a result of her immigration status. Today, the hospital would likely work with the mother to enroll the child in Medicaid, so that the hospital could be paid for the child’s treatment. But with the new regulations in place, the mother might fear that enrolling her child in Medicaid would adversely affect her ability to get a green card and stay in the United States with her child. As a result, the mother’s interest and the hospital’s would be in conflict. Situations like this will likely arise every day, as patients fear enrolling in insurance to which they are entitled.

The regulations may also cause problems for many health care workers. While immigrants make up about 8 percent of the overall American workforce, they constitute 16 percent of the health care work force. Most non-citizen physicians and registered nurses receive health insurance through work, and will not be significantly affected by the proposed regulations. However, 22 percent of low skilled jobs in the health care sector, including nursing home workers and personal attendants, are filled by immigrants, many of whom lack access to employer-provided insurance.

For example, 25 percent of the home health aide workforce is non-United States born and one-third of home health aides rely on publicly-funded programs, including Medicaid and the ACA’s premium tax credits for insurance. If they avoid such programs for fear of becoming a public charge, they are likely to be uninsured, and unable to receive necessary care. That is likely to affect their ability to stay healthy and be productive workers. Making matters worse, the expanded definition of public charge will likely make it harder for low-skilled immigrants, including those who would otherwise work in the health care sector, to enter or stay in the country.  

The Administration defends the proposed regulations on the theory that they will advance self-sufficiency among immigrants. Self-sufficiency is an articulated goal in our immigration laws. But immigration law also establishes that many classes of immigrants are qualified for and entitled to federally-funded health benefits. So do many of our health laws, including the ACA and the laws authorizing CHIP. These laws reflect the realization that self-sufficiency with respect to health care is unrealistic. When it comes to health care, very few people are truly self-sufficient. Almost everyone needs insurance, and even the forms of insurance that the regulations favor depend upon public’s support. For example, employer-provided insurance receives preferential tax treatment, and Medicare is financed in part from general tax funds. And all but the very wealthy can find themselves relying on Medicaid or other public programs if a serious accident or disability befalls them.

Not only is self-sufficiency in health care unrealistic, it makes for bad health policy. The proposed regulations may be aimed primarily at keeping out unskilled workers, but by deterring taxpaying immigrants from accessing necessary care, they will spread costs throughout the health care system, add to health-related work losses, and harm the health of children and families.

There are still many steps before some version of the proposed regulations become law. The proposal is currently before the Office of Management and Budget, which could demand changes. It would then need to be published in the Federal Register for public comment. Should that happen, it is imperative that those who care about patients and the health care system weigh in, lest the Administration’s war against immigrants becomes a war against the American health care system.

Q&A: Holding Drugmakers Accountable for Opioid Crisis

Recently, George Consortium member and University of Michigan professor Rebecca Haffajee gave an interview to the Associated Press, addressing issues around opioid companies and litigation:

“Q: Why didn’t early lawsuits filed against opioid drugmakers have much success?

A: The earlier lawsuits were typically brought by individuals and were vulnerable to a number of defenses from the manufacturers. The companies could argue that individuals misused the prescription drugs or prescribers weren’t providing adequate medical advice about the products. Companies also argued that they were marketing and selling their products in accordance with Food and Drug Administration rules for these FDA-approved products.

Many of those cases were dismissed. Sometimes the individuals bringing the suits simply ran out of resources to pay for the litigation.

Q: Why are these newer lawsuits different?

A: Governments are bringing these more recent lawsuits, and they are alleging harms to their overall social systems that (acknowledge) misuse was happening, but regardless, are trying to hold companies accountable.

The idea is that these companies must have known, based on their own records and information, that the mass selling and distribution of opioids had gone beyond their appropriate medical use. The defense that people misused these drugs doesn’t hold as much weight in these cases.

Q: People have compared this litigation to the lawsuits against Big Tobacco in the 1990s that resulted in a nearly $250 billion financial settlement for state governments. What are some of the differences?

A: Part of the idea with tobacco was to get this product off the market altogether. With opioids we don’t want that. We want to be limiting the amount of opioids prescribed and misuse, but we recognize these are FDA-approved products that have a medical use and can be appropriate and effective, particularly for acute pain. The idea here is to try and thread the needle and allow appropriate use, but rid the market of inappropriate use.

Q: Beyond a financial settlement, many government officials say they want to change how this industry does business. Is that likely to happen?

A: That certainly can be a byproduct of the litigation, changing marketing practices and behavior. If it’s a penalty that’s big enough, it could have a deterrent effect.

Some of the recent settlements we’ve seen with drug distributors and manufacturers have required that they report certain information or refrain from certain conduct going forward.”

Public Health Law Watch Comments on HHS Regulation Proposal: Protecting Statutory Conscience Rights

Public Health Law Watch, joined by our friends at the Public Health Law Center, submitted official comments to the U.S. Department of Health and Human Services proposed amendments to 45 CFR 88, "Protecting Statutory Conscience Rights; Delegations of Authority." Based on our combined expertise in public health law and policy, we offered comments on five main issues: (1) the lack of evidence that these rule revisions are necessary; (2) the absence of consideration for patients who face refusal of care; (3) the potentially dangerous expansion of existing definitions around “conscience protections;” (4) the potential harm these rules will cause for the LGBTQ population; and (5) the detriment these proposals would cause to reproductive health and rights.

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U.S. Department of Health and Human Services

Office for Civil Rights

RIN 0945-ZA03Docket

HHS-OCR-2018-0002

Public Health Law Watch (PHLW) and the Public Health Law Center appreciate the opportunity to make comments on the proposed Department of Health and Human Services (HHS) revisions to 45 CFR Part 88, “Protecting Statutory Conscience Rights; Delegations of Authority.” PHLW is a project of the George Consortium, a nationwide network of public health law scholars, experts, and practitioners.  The Public Health Law Center is nonprofit affiliate of the Mitchell Hamline School of Law, and a leading center of expertise in the use of law to prevent chronic disease.  The Center’s team of lawyers, law students, policy analysts and graduate students helps health leaders nationwide create communities where everyone can be healthy, with a focus on promoting healthy eating, encouraging physical activity, reducing the use of tobacco products, supporting health equity, and addressing cross-cutting legal issues that affect the nation’s health. Based on our combined expertise in public health law and policy, we offer the following comments on five main issues: (1) the lack of evidence that these rule revisions are necessary; (2) the absence of consideration for patients who face refusal of care; (3) the potentially dangerous expansion of existing definitions around “conscience protections;” (4) the potential harm these rules will cause for the LGBTQ population; and (5) the detriment these proposals would cause to reproductive health and rights.

First, we question the need for these regulatory revisions. As laid out in the Supplementary Information accompanying the proposed regulations, federal law already contains a plethora of provisions that protect individuals who invoke a religious objection to providing certain types of care, including abortion and assisted suicide. Yet, that information contained scant evidence that a pervasive discriminatory environment towards individuals and institutions who invoke these protections actually exists.  Rather, while the evidence provided describes an uptick in “conscience” complaints since the election of President Trump in late 2016, a total of only 44 complaints have been made since 2008. That represents less than 0.2% of the estimated 25,000 complaints that the HHS Office of Civil Rights (OCR) receives every year. Most of the remaining claimed support in the accompanying information is based solely on anecdotal commentary rather quantifiable data. Expanding these existing protections also risks directly conflicting with numerous professional standards, including the American Medical Association acknowledgement that conscience protections are not unlimited and that physicians “are expected to provide care in emergencies, honor patients’ informed decisions to refuse life-sustaining treatment, and respect basic civil liberties and not discriminate against individuals in deciding whether to enter into a professional relationship with a new patient.”  The current version of 45 CFR Part 88 is fully adequate to properly address existing and potential complaints about conscience protection violations. HHS can also fully institute its stated goals of ensuring “knowledge, compliance, and enforcement” of existing conscience protections via administrative means that do not require revising and expanding the current regulations.

Second, we are concerned that the regulations contain no protections for patients who face denial of care when health care providers and entities invoke these “conscience protections.”  By leaving patient consideration out, these regulations not only devalue those patients as individuals, but also potentially put their lives at risk. We have no way to know exactly how many times such “conscience protections” have been invoked or the extent of harm caused, but we do know that providers have, for example, refused to inseminate a woman because of her sexual orientation, refused to help a profusely bleeding pregnant woman because the fetus would not survive the procedure necessary to save her life, and refused to transport a pregnant woman by ambulance to a clinic that provided abortions. As the American Academy of Family Physicians has emphasized, “There is a distinct difference between declining to participate in a procedure versus denying access to care to an individual patient. The former is a protected right, the latter is an unacceptable shirking of our basic responsibility to care for our patients and contrary to the key underpinnings of the Code of Medical Ethics.”  Even if OCR prioritizes “conscience protections” of the health care providers and entities, the regulations also need to adequately protect the health and lives of the patients affected when such conscience protections are invoked. Further, the regulations are focused solely on health care providers and entities that refuse to provide certain types of care, yet fail to protect health care workers who view providing services like abortion as moral imperatives and yet face constant barriers and little consideration for their views.

Third, though the regulations are intended to enforce the “conscience protection” provisions in federal law, several of the proposed definitions in section 88.2 are so wide as to significantly expand existing law. We are particularly alarmed about the broad proposed definition of the term “referral or refer for.” While some of the existing provisions include a right for health care workers not to provide a “referral” for a service they have a religious or moral objection to, this definition of referral includes “the provision of any information…by any method… that could provide any assistance in a person obtaining….a particular health care service, activity, or procedure[.]” (emphasis added). This expansive definition conceivably allows a health care provider to not only refuse to provide a direct referral for care, but also to present the health care services he or she is willing to perform as the only medical options available to the patient. This could deprive a patient of the ability to make a decision with informed consent and leave them unaware that they can seek alternative and appropriate care from another provider. Again, these regulations provide no recourse to a patient harmed by this situation; rather, the regulations consider only the provider.

Compounding the concern about the broad definition of “refer,” the terms “workforce” and “assist” also have definitions that include activities, omissions, and persons far beyond the scope of those already protected under federal law. “Workforce” includes not only health care entity employees and contractors but also includes unpaid volunteers. “Assist in the performance” means “to participate in any program or activity with an articulable connection to a…” procedure, activity, or program. This explicitly includes, but is not limited to, “counseling, referral, training, and other arrangements….” These exceptionally broad definitions expand the scope of those who can invoke “conscience protections” beyond those originally envisioned in many of the federal provisions at issue. By allowing such a broad population of individuals to invoke “conscience protections” in such a wide range of situations, the care of patients is further diminished. This particularly puts at risk the health of patients in areas with few existing resources; low-income U.S. residents are already more likely to live in areas with fewer physicians and fewer hospitals and to have significantly poorer health overall. Residents in rural and farm communities also face similar barriers to access and health disparities.  The regulations should ensure adherence to the federal laws so that they apply narrowly and therefore minimize the impact on patient care.

Fourth, we are deeply concerned that these regulations particularly imperil care of the LGBTQ population. Health care already has a long history of anti-LGBTQ discrimination, such as classification of homosexuality as a psychiatric disorder and “treatment” that included electroshocks and “conversion” therapy. Partially as a result of this harm, LGBTQ populations have numerous health disparities, including higher rates of HIV, suicidal ideation and attempts, and violence victimization. They face frequent discrimination in health care contexts and these regulations would only enhance that discrimination by allowing a health care worker to raise a “moral objection” to, for example, homosexuality in general or to same-sex marriage. The objection could conceivably even be invoked to refuse treatment to children who have same-sex parents. Within the LGBTQ community, the transgender population is particularly at risk under these regulations. Absolutely no evidence exists that health care providers are being forced, for example, “to perform gender-affirming surgeries against their will…but what is happening every day, is transgender patients are being denied every kind of medical care you can think of.” A full 22% of transgender people in America already avoid doctors and medical care due to fear of discrimination and 31% have no access to regular health care at all. Those numbers are already alarming in the context of public health; these regulations risk leading to even wider denial of care, which would only increase that crisis.

Finally, the health care services explicitly targeted most often by these regulations (and by existing federal law) are those involving reproduction. In fact, the regulations often seem to be directly intended to “undermine existing legal and ethical protections for patients’ access to sexual and reproductive health information and services, and other critical care.” Many of the existing federal provisions explicitly allow providers and entities to invoke conscience protections in relation to directly providing abortions. But conscience protections have also been invoked to refuse access to emergency contraception for rape victims and to refuse to perform medically necessary procedures to save a woman’s life. The United States already has the worst rate of maternal deaths in the developed world, and this issue is further compounded by significant disparities: black mothers die at a rate 3-4 times more often than white mothers. To allow health care providers to invoke conscience protections to lifesaving reproductive health care even as a woman dies will escalate already unacceptably high rates. Further, these regulations also target – according to the supplementary information provided - laws requiring insurance coverage of reproductive health services, public notice requirements for “crisis pregnancy centers,” and attempts to require hospitals and healthcare professionals to provide abortion care when a woman’s life is endangered. These provisions go well beyond what the federal law currently covers, dangerously encroaching not only on a constitutionally protected right to reproductive health care but also on the very lives of women as patients. 

While protecting religious convictions has indeed been a long-respected – though never unlimited - right in the United States, HHS’s proposed regulations prioritize expansion provider protections without adequate consideration for how they endanger the health and lives of already vulnerable patient populations. We urge HHS not to adopt these proposed regulations.

Sincerely,

PHLW and PHLC

Public Health Law Watch

A project of the George Consortium

Publichealthlawwatch.org

Public Health Law Center

Publichealthlawcenter.org

Legal Skills Through a Health Justice Lens: First-Year Northeastern Law Students Work Toward Health, Equity, and Justice for Two Oppressed Groups

We have a really special post today - George Consortium member Jason Potter describes his innovative work as a professor and the work of his students here at Northeastern University School of Law. These first year law students studied legal skills through a lens of health justice and turned health justice theory into practice by partnering with non-profit organizations and creating tangible guidance on issues of safe consumption facilities and barriers to health care for transgender individuals. The students will present their work at two upcoming community presentations - if you are local to Boston, please join us!

Law Office 7’s presentation of their research to the community, entitled, Establishing a Safe Consumption Facility in Massachusetts: An Interdisciplinary Review of Legal Barriers and Avenues to Harm Reduction, will take place on Thursday, Mar. 29, 2018, from 2:00-3:00 p.m. in 160 Dockser Hall (Forsythe Street entrance).

Law Office 8’s presentation of their research to the community, entitled Winning Gender-Affirming Care for Transgender Medicaid Recipients in New York, will take place on Thursday, Apr. 5, 2018, from 2:00-3:00 p.m. in 160 Dockser Hall (Forsythe Street entrance).

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By Jason Potter, Associate Teaching Professor, Northeastern University School of Law

Poor health in any population affects everyone. Poor heath negatively affects, inter alia, the economy, wages, property values, education, healthcare costs, and crime rates. Despite legislative innovations mandating access to care, from EMTALA to the Patient Protection and Affordable Care Act, improvements in the health of impoverished and minority populations remain incremental. Institutional racism, stigma, and bias—in the healthcare industry, in education, in employment, in social structures, and in legal systems—negatively impact the health of low-income, minority, immigrant, disabled, and non-conforming communities. As one scholar noted, the principles of “[h]ealth, equity, and justice” are the “keystones of a . . . thriving society,” and uniform application of these principles to all populations is a moral imperative. Today, these principles remain unfulfilled.

Social justice has been described as “a communitarian approach to ensuring the essential conditions for human well-being, including redistribution of social and economic goods and recognition of all people as equal participants in social and political life.”  Social justice and health are inexorably linked. According to Amartya Sen, “[i]n any discussion of social equity and justice, illness and health must factor as a major concern.” Sen further noted that “health equity cannot be but a central feature of the justice of social arrangements in general.” A “health justice” movement that treats law as a tool for achieving health, equity, and justice is well underway in the legal academy, and in legal education.

At Northeastern University School of Law, I teach in an innovative experiential program called “Legal Skills in a Social Context” (LSSC). In the LSSC Program, teams of first-year students (known as “law offices”) examine the complex interplay among law and diversity, values, and institutional oppression alongside learning traditional lawyering skills such as legal writing and research. Each law office partners with a nonprofit or government organization to complete a year-long social justice project. Given my interest in social determinants and the centrality of health to core social justice principles that also frame LSSC discourse, approaching the course through the lens of health justice and social determinants seemed both inevitable and novel. As it turns out, my students are likely the only first-year law students in the United States learning foundational legal writing in a health justice context.

Over the 2017-2018 academic year, my “law offices” served two oppressed and underserved groups of people. First, LSSC students in “Law Offices 7” confronted the enormous challenges facing people who use drugs (PWUD). There are significant “downstream” health consequences when drug enforcement laws are a primary means of addressing the harms of drug use. PWUD face “consequences associated with disclosure, including loss of employment, loss of housing, loss of child custody, loss of benefits, discrimination by medical professionals, and even arrest, prosecution, and incarceration.” Yet the view that addiction amounts to a moral failing, despite scientific evidence showing it is a chronic medical illness, remains the dominant one in the United States, particularly with respect to those who inject drugs. The resulting stigma and discrimination create an immense barrier to recovery and health for PWUD. Second, “Law Office 8” examined the unique healthcare needs of transgender individuals—needs that are problematized by discrimination in nearly every system, including the medical system. Of the 27,715 respondents to the 2015 National Transgender Discrimination Survey (conducted by the National Gay and Lesbian Task Force), 25% of respondents reported having difficulty with insurance related to their transition, and of the 87% of respondents who had sought care in the past year, 33% of them had at least one negative experience with a provider. Nearly a quarter of respondents reported that they needed care but didn’t seek it due to concerns about provider mistreatment. In their own unique ways, transgender individuals and PWUD both face significant barriers to health as a result of oppression.

Law Office 7’s project, on behalf of AIDS Action Committee of Massachusetts, addressed, among other things, the nearly impervious set of federal and state drug laws that could thwart the establishment of an effective point of healthcare engagement for PWUD—the first Safe Consumption Facility (SCF) in the Commonwealth. In its traditional sense, an SCF is an environment, equipped with medical staff and equipment such as naloxone and clean needles, created for the purpose of reducing harm to clients as they consume pre-obtained drugs. The team used the traditional SCF model as the main vehicle for analysis, but also considered different SCF models (such as clinical and mobile medical unit models), and examined how these models interact with the Controlled Substance Act (CSA), federal regulations, the Massachusetts CSA, state regulations, zoning restrictions, and other requirements. Finally, the team explored potential ways forward in Massachusetts and provided general legislative recommendations. Law Office 7’s presentation of their research to the community, entitled, Establishing a Safe Consumption Facility in Massachusetts: An Interdisciplinary Review of Legal Barriers and Avenues to Harm Reduction, will take place on Thursday, Mar. 29, 2018, from 2:00-3:00 p.m. in 160 Dockser Hall (Forsythe Street entrance).

Law Office 8’s project, on behalf of the Legal Aid Society of New York, involved the challenges facing transgender New York residents in accessing medically-necessary, gender-affirming health care despite laws that guarantee Medicaid coverage for such care. The team created a guide with the aim of assisting a wide audience of attorneys, advocates, and individuals attempting to navigate the complex Medicaid and fair hearing process in New York. The comprehensive guide introduced transgender cultural competency, explored the process of accessing Medicaid benefits for gender-affirming care, furnished detailed steps for Medicaid recipients facing care denials and the internal insurance grievance process, discussed preparation and expectations for the fair hearing process (setting forth advocacy tips and practitioner insights), and described potential next steps in the event of an unfavorable fair hearing decision. The team’s goal in creating the guide was to provide insight and instruction on navigating the entire process of receiving Medicaid benefits for gender-affirming care, from beginning to end. Law Office 8’s presentation of their research to the community, entitled Winning Gender-Affirming Care for Transgender Medicaid Recipients in New York, will take place on Thursday, Apr. 5, 2018, from 2:00-3:00 p.m. in 160 Dockser Hall (Forsythe Street entrance).

The principles of health, equity and social justice are not satisfied “when they do not apply equally to all members of society.” Explicit, implicit, and structural biases continue to shape the healthcare experiences of transgender individuals and PWUD, which negatively affects health outcomes in these communities. At the mercy of systems that are neither designed to consider their unique healthcare needs nor the social determinants of health, many transgender individuals and PWUD are incapable of realizing their full capabilities as human beings. This year, NUSL’s LSSC Students in Law Offices 7 and 8 didn’t just study health justice. They turned health justice theory into practice.

For more information about partnering with LSSC on a health justice project, visit the LSSC website and reach out to me directly (j.potter@northeastern.edu).

The PORTAL Literature Scan for March

Every month, our friends at the Program on Regulation, Therapeutics, and Law (PORTAL) - part of a collaboration between Harvard Medical School and Brigham & Women’s Hospital - publish a great list of the best and most interesting studies, policy analyses, and editorials about regulation, therapeutics, and law. Below, we're featuring one in particular co-authored by George Consortium member Lainie Rutkow. You can find the rest of this month's list here:  https://www.portalresearch.org/literature-scan.html

Impact of Florida's prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis.    
Chang HY, Murimi I, Faul M, Rutkow L, Alexander GC.  
Pharmacoepidemiol Drug Saf. 2018 Feb 28. [Epub ahead of print] 
Compared with Georgia, Florida's prescription drug monitoring program and pill mill law were associated with large relative reductions in prescription opioid utilization among high-risk patients... Read More

 

Medicaid Work Requirements Would Put Very Few People to Work [from philly.com]

[crosspost from Health Cents, philly.com]

By Robert I. Field

The Trump administration recently agreed to let states get tough on Medicaid recipients who don’t work. Kentucky was the first to win approval of a plan to kick those who can work but don’t off the roles, and at least ten other states would like to do the same. Under these plans, in order to maintain coverage, able-bodied adults would have to prove that they are either employed in some form or are actively trying to be.

Will we now see a lot of lazy people among Medicaid’s almost 68 million recipients forced to join the workforce or lose their free health care? Almost certainly not. The new requirements would apply to only about one percent of all Medicaid beneficiaries.

Let’s look at who currently receives Medicaid and do some simple arithmetic. According to the nonprofit Kaiser Family Foundation, about 10% of Medicaid recipients are elderly, age 65 and older, and many of them are in nursing homes. About 48% are children, age 18 and younger. That leaves about 42% who are of working age and potentially subject to the requirements.

Of those would could be subject to the rules, 42% are already working full-time, and 18% are working part-time. Another 14% are not working due to illness or disability, six percent are in school, and 12% are caregivers for family members. All of them would be exempt.

That leaves just seven percent who could be forced to work. But most of them are already looking for jobs. When active job seekers are taken into account, less than three percent of adult beneficiaries would feel the effects of the new rules. That is about one percent of all Medicaid recipients.

Why would states go through the effort of implementing a new program to reach such a small percentage of the Medicaid population? Most state Medicaid agencies would have to hire new staff to administer the rules, and the cost could exceed any savings that could be achieved.

Advocates of work rules claim that putting people to work will make them healthier, regardless of any cost savings. But even if more than a tiny percentage of beneficiaries were involved, this claim has almost no evidence to support it.

However, there may be another reason for the rules that has little to do with actually putting people to work and more to do with the way the requirements would be implemented. The rules would require most Medicaid recipients to prove that they are either exempt, can’t work, have a job, or are looking for one. Kentucky would require them to do this every month or risk losing benefits for the next six months.

Offering that proof could impose a substantial paperwork burden. Some beneficiaries, particularly the elderly and disabled, could find it especially difficult. Even able-bodied adults could find the documentation requirements challenging.

As a result, the work requirements could pare Medicaid roles of many more people than just those who are employable but not working. And many of those losing benefits would be people who desperately need health care and would now find it unobtainable. That would certainly save costs, but it’s a brutal way to do it.

Innovation to improve Medicaid is surely welcome. But work requirements would do nothing to improve the program while posing the risk that many people who are fully entitled to benefits would suffer real harm.