The Promising Potential of Gun Violence Protection Orders

By Elisabeth J. Ryan

While mass shootings account for just a small fraction of the more than 36,000 lives lost to firearms in the United States every year, these devastating, large-scale events have become not only more frequent but also deadlier in recent years. On February 14, a student who had been expelled from school returned to Marjory Stoneman Douglas High School in Parkland, Florida and killed 17 people using a high-powered AR-15 rifle. At first, the cycle of outrage, grief, “thoughts and prayers,” and demands for gun law reform seemed doomed to repeat and fizzle out, as they already had many times after many similar mass shooting tragedies. But something new emerged out of Parkland – the surviving students who refused to remain silent about gun law reform and refused to back down in the face of politicians and the NRA who advocate for fewer restrictions on guns, such as nationwide concealed carry reciprocity. But in large part due to the Parkland students’ indefatigable activism, the gun lobby has not been able to triumph again via a quiet return to the status quo. Instead, some serious and concrete discussions about gun law reform have taken place across the country. While some suggestions - like the President’s NRA-backed idea of arming teachers - are patently unrealistic; others – like “red flag” laws – have both potential political viability and established track records.

“Red flag” laws are also known as “gun violence protection orders” or “extreme risk protection orders” and refer to legal provisions that allow a petitioner to go to court and seek an order to seize another person’s guns if that person presents a danger to himself or to others. Five states have some version of this law – California, Connecticut, Indiana, Oregon, and Washington - and Rhode Island’s governor issued one via an emergency executive order this week as well. Several other states, including Massachusetts and New Jersey, have bills pending to create similar laws. The laws vary somewhat in details such as who can petition, the burden of proof required, and the process for challenging a seizure. But the overall purpose is the same – instituting a judicial process that allows for the emergency removal of firearms from the possession of a person posing a risk of harm to themselves or others.

These laws are perhaps particularly relevant in the wake of mass shootings like the one in Parkland because they offer a concrete way for a concerned person close to a potentially dangerous individual to seek a specific, court-sanctioned action that removes firearms from their access. The shooter in Parkland was of legal age, bought a legal gun, and legitimately passed all the required background checks, but people who knew him saw signs of potential danger. While some have blamed mental illness for that danger and claimed that firearms violence is a “mental health issue” rather than a “gun issue,” that perspective merely risks further stigmatizing people with mental illness as a whole, while doing nothing to actually provide additional services to anyone. Further, the link between mental illness and violence is extremely weak: “A 2015 study found that less than 5% of gun related killings in the U.S. between 2001 and 2010 were committed by people diagnosed with mental illness.”

Whether the existence of one of these laws would have prevented the massacre in Parkland is, of course, impossible to know. But when Florida Judge Steve Leifman, who chairs the Florida Supreme Court Task Force on Mental Health, was asked what authority he would want as a judge to play a greater role in preventing mass shootings, he answered, “So in Florida, we do not have the authority to take guns away from people that may have been found dangerous to self or others. We only have authority to put them on a list to stop the purchase of the firearm. But if they already own a gun, there’s nothing we can do, which makes no sense at all.”

That same sentiment lead Connecticut to enact the first “red flag” law almost 20 years ago. In 1999, Connecticut passed a relatively large firearms reform package spurred by implementing the National Instant Criminal Background Check System (NICS). In 1993, the Brady Handgun Violence Protection Act created a plethora of new federal firearms reforms, including the establishment of NICS, a centralized federal database that searches records every time someone tries to purchase a firearm from a federally licensed firearm dealer. NICS implementation depends on the cooperation of the states to submit such records, so states were tasked with adjusting their own laws and procedures to facilitate those transfers. When NICS became live in 1998, Connecticut acted swiftly to enact enabling legislation and further used the opportunity to pass multiple additional firearms-related statutes.  This included a first-in-the-nation procedure to seize the firearms of a person posing a risk of injury to themselves or to others. This novel law, though sometimes derided as the “turn-in-thy-neighbor act,” was created as “a very small, but important opportunity to intervene before it is too late.”

Before passage, one politician warned that this scheme would lead annoyed neighbors to maliciously call the police on each other, leading to situations in which armed-and-ready police officers burst through the door of legal gun owners, risking the lives of innocent families. He likened it to “1939 Germany.” Fellow politicians countered that the law was actually “extraordinarily tame” and had “very tight judicial controls.” The same arguments for and against such laws still exist, though bipartisan support is perhaps showing more promise. (The return to “1939 Germany” do not seem to have been realized in Connecticut).

The original Connecticut law created a roadmap for the handful of states that came after it, which somewhat tweaked and tailored their approaches, but kept the basic concept intact. In Connecticut, a prosecutor or any two police officers can petition a judge to grant a warrant allowing them to seize a person’s firearms and ammunition. To do so, they have to prove probable cause to believe that the “person poses a risk of imminent personal injury to himself or herself or other individuals,” that the person possesses firearms, and that they firearms are in a searchable place. The law requires that, before even applying for the warrant, the prosecutor or officers have to conduct an investigation to determine not only probable cause, but also that “no reasonable alternative [was] available to prevent such person from causing imminent…injury…” In the warrant application process, the judge is required to consider any recent threats or acts of violence directed towards the person’s self or others, as well as any recent acts of cruelty to animals. The judge may also consider evidence of any reckless use, display, or brandishing of firearms; history of the use, attempted use, or threatened use of physical force against other persons; prior involuntary confinement of such a person in a psychiatric hospital; and illegal use of controlled substances or abuse of alcohol.

The Connecticut law also mandates that the court hold a hearing within 14 days of the warrant’s execution, requiring a determination as to whether any seized firearms should be returned to the person named. The state has the burden to prove, by clear and convincing evidence, that that the person does pose a risk of imminent personal injury to himself or to others. If the court finds the state has met is burden, it may order that the state continue to hold the firearms for up to one year. It must also advise the state Department of Mental Health and Addiction Services, which can then determine whether to initiate involuntary commitment proceedings.

The most common changes to more recent firearm seizure law haves been to expand the potential petitioners to include family and household members and to shift from a warrant-based system to one more akin to a domestic restraining order, requiring a burden of either preponderance of the evidence or clear and convincing evidence, as opposed to probable cause.  The recent laws also generally include a provision allowing the subject of the order to request a termination hearing at least once during the one-year pendency of an order.

The Connecticut firearms seizure law has been challenged as a violation of the Second Amendment only once in published court decisions. Echoing the Supreme Court’s language in District of Columbia v. Heller, the Appellate Court of Connecticut disposed of the argument succinctly, stating in a 2016 case that the law “does not implicate the Second Amendment, as it does not restrict the right of law-abiding, responsible citizens to use arms in defense of their homes. It restricts for up to one year the rights of only those whom a court has adjudged to pose a risk of imminent physical harm to themselves or others after affording due process protection to challenge the seizure of firearms. The statute is an example of the longstanding ‘presumptively lawful regulatory measures.’” No other Second Amendment challenges to these laws seem to have made their way to any other state appellate courts.

As the movement gains momentum towards more of these “common sense gun solution” red flag/gun violence protection orders states must also “do a better job of informing the public how these laws work…[because] even in the few states with red-flag laws, family members and police are often unaware of them.” Having such potentially promising policies on the books accomplishes little if no one knows how to utilize them.

Fighting Fire With Lighter Fluid: Trump Administration Housing Policy Proposals Would Exacerbate the U.S. Affordable Housing Crisis, Heightening Health Inequities

By Madeline Morcelle

Emerging policy proposals from the Trump administration would exacerbate U.S. affordable housing crisis, heightening heath inequities. On February 12, the Trump administration released its 2019 budget proposal, advocating for deep cuts to already chronically underfunded housing programs, as well as drastic rent increases and reforms to encourage “work and self-sufficiency” for low-income individuals and families receiving rental assistance. Draft legislation (1) leaked from the Department of Housing and Urban Development (HUD) earlier this month articulated these proposals in greater depth.

Affordable, adequate, and stable housing is fundamental to physical and behavioral health. Housing stability empowers individuals to maintain health care access, properly store medications, and lead healthier lives. In contrast, housing instability and homelessness are immense barriers to health, creating new health problems and magnifying existing ones. Low-income families and individuals burdened by housing costs must sacrifice other vital health-related needs, from healthy food to health care. People living in unsafe and crowded shelters or on the streets are at increased risk of hospital and emergency department utilization, communicable conditions, and death from drug overdose. There is no health equity without housing equity.

If unaffordable housing and homelessness are public health issues, then the U.S. is experiencing a full-on public health crisis, with no state or city left unscathed. Last year, the National Low Income Housing Coalition found that the U.S. has a shortage of 7.4 million affordable (2) and available rental homes for extremely low-income households (3), with only 35 units for every 100 households. Total homelessness increased for the first time in seven years. On a single night, more than half a million individuals were sleeping on the streets, in shelters, or in their cars.

Under current funding levels, only 1 in 4 low-income households eligible for federal rental assistance receive it, and many sit on waiting lists for years. Yet, the Trump administration’s budget request asks Congress to slash discretionary HUD funding by $8.8 billion or 18.3 percent compared to 2017 enacted levels. This would gut existing resources, eliminating at least 200,000 housing vouchers alongside other aids and placing thousands of families receiving assistance on the road to eviction or even homelessness.

Those maintaining housing assistance would weather significant rent increases, leaving less income for food, health care, and other basic health-related needs. Under current law, families receiving housing assistance generally pay the 30 percent of their adjusted income or 10 percent of their gross income for rent, whichever is higher. The draft legislation would dramatically increase minimum housing costs. At a minimum, elderly and disabled families would pay the greater of 30 percent of monthly gross income or $50 in monthly rent. Other families would pay at least 35 percent of gross income or $152.25 in monthly rent, whichever is higher. Public housing agencies and project-based housing providers could increase rent up to 50 percent of monthly gross income. Because the legislation would also eliminate key deductions for necessities in the calculation of rent contribution, families with high unreimbursed medical or child care expenses—both excluded from adjusted income under current law—could be hit the hardest.   

The draft legislation obtained by the author would also grant housing providers broad authority to impose arbitrary work requirements on residents, mirroring similar pushes in Medicaid and the Supplemental Nutrition Assistance Program. Public housing agencies and project-based Section 8 housing providers could require up to an average of 32 hours per week per adult on all or a portion of families occupying dwelling units. These proposals ignore the reality that 9 in 10 households receiving HUD rental assistance are elderly, disabled, working, or receive Temporary Assistance for Needy Families (TANF) assistance. In 2016, 57 percent of households who received federal housing assistance were elderly or disabled. Seventy-four percent of non-disabled and working-age households worked or were TANF recipients largely subject to work requirements. Myriad barriers ranging from severe and chronic health conditions to caregiving responsibilities and irregular work scheduling can explain why the remaining families struggle to secure and sustain employment. Imposing punitive work requirements on these families will not lift them out of poverty. It will sever a lifeline.

If the administration were serious about promoting sound public health policy and self-sufficiency, fighting the opioid epidemic, and improving the efficiency and effectiveness of administrative services across government, it would ensure adequate housing assistance for those in need. Instead, its housing policy proposals fight fire with lighter fluid, cutting and creating new barriers to critical health-related resources when America needs them most.

(1) On file with author.

(2) The federal standard for affordable housing is that no more than 30% of a household’s gross income should be spent on rent and utilities.

(3) “Extremely low-income families” are those whose incomes do not exceed the higher of the Federal poverty level or 30 percent of Area Median Income.

A Response to "Unintended Consequences: Medicaid and the Opioid Crisis"

Today, Public Health Law Watch sent a letter (both electronically and on paper) to every member of the U.S. Senate Committee on Homeland Security & Governmental Affairs in response to a January hearing entitled "Unintended Consequences: Medicaid and the Opioid Epidemic." That hearing and its accompanying report presented a slew of misinformation, misleading statistics, and poorly informed conclusions that attempted to blame the current opioid crisis on the expansion of Medicaid. The George Consortium members mobilized to respond with facts and real potential solutions.

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Dear Chairman Johnson and Ranking Member McCaskill:

We, the undersigned, are deeply concerned about a January 17 United States Senate Homeland Security and Governmental Affairs Committee hearing entitled “Unintended Consequences: Medicaid and the Opioid Epidemic,” and its accompanying published report entitled “Drugs for Dollars: How Medicaid Helps Fuel the Opioid Epidemic.” Instead of discussing evidence-based responses to the opioid crisis, both the hearing and report are riddled with inaccurate information, misleading statistics, and poorly informed conclusions. All told, these actions appear aimed at demonizing Medicaid recipients as, at best, interlopers and, at worst, criminals who obtain “free” opioids by fraud and then sell them on the black market for profit. Not only is this blatantly harmful stereotyping of individuals who rely on Medicaid for vital access to health care, but this hearing and report also appear to blame the Medicaid expansion portion of the Affordable Care Act for a very real crisis that kills upwards of 100 people every single day in the United States.

There are numerous failures in empirical analysis and logic in the narrative that links our national overdose emergency with Medicaid expansion. First and foremost, the upward trajectory in opioid deaths accelerated long before the Affordable Care Act Medicaid expansions. The Medicaid expansion did not begin until January 2014. Notably, overdose deaths involving prescription drugs generally slowed and plateaued after 2011 before another rise in 2016.

Second, states with above average opioid overdose death rates include both Medicaid expansion and non-expansion states. While expansion states did have a slightly higher rate of drug deaths than non-expansion states in 2015, that upward trend began in 2010, several years before the expansion itself.  The expansion could not have caused the increase because it did not precede the effects. In fact, it is conceivable that rising opioid-related deaths may have influenced states’ decisions to implement the Medicaid expansion in the first place. Further, the increase in deaths happened across virtually all insurers, not just Medicaid.

Medicaid beneficiaries do have a higher rate of opioid use disorder than privately insured individuals and are prescribed pain relievers at higher rates than those with other sources of insurance.  This is largely because the Medicaid program serves a patient population more vulnerable to higher rates of disability and chronic illnesses compared to the general population. Medicaid recipients have reported daily (or almost daily) pain at rates double that of non-Medicaid recipients. This vulnerable population also faces other life and logistical challenges independent of health care coverage - such as lack of transportation, comorbidities, and inflexible work demands - that make it more difficult to avoid adverse health outcomes. 

Access to opioids is easier with any health insurance coverage, not just Medicaid.  And when access to opioids is restricted, people begin to use more illicit drugs than prescriptions.  For example, Kentucky passed a law imposing strict prescription limits. As intended, this sharply reduced the number of opioid prescriptions written. However, opioid mortality did not drop. Similar laws in Florida and Ohio led to declines in prescription pill overdose deaths but coincided with a massive increase in heroin overdose deaths. Indeed, opioid overdose deaths after Medicaid expansion have spiked largely due to illicit fentanyl and heroin, rather than prescription opioids.

Rather than causing the opioid crisis, Medicaid has been and should remain part of the solution. The Medicaid expansion has greatly improved access to substance use disorder treatment. Medicaid provides coverage for nearly 4 in 10 nonelderly adults with opioid addiction. Expansion created greater access to services such as medication-assisted therapy and case management, with a documented 70% increase in prescriptions of buprenorphine to treat opioid use disorder—treatment that can slash a patient’s overdose risk by half. Medicaid is key in addressing the opioid crisis, not in creating it. Beyond direct treatment services, Medicaid also has the potential to address social risk factors by, for example, reimbursing supportive housing services shown to improve the health of those with substance use disorders.

Finally, medication diversion does occur, but it is driven substantially by unaddressed health needs and structural problems, which also fuel misuse. And such issues are not caused by Medicaid; they occur when people are covered by Medicare and private insurers as well. The response should not be to deny health care to the Medicaid population but to address the underlying drivers of addiction, such as “economic and social upheaval…, physical and psychological trauma, concentrated disadvantage, isolation, and hopelessness.”  Rather than focus on punitive measures such as criminal prosecution and slashing aid to Medicaid and individual recipients, the government should focus on harm reduction strategies such as expanding access to medication-assisted treatment, supporting safe injection sites, increasing awareness of and access to Naloxone, and truly treating this crisis as a serious public health emergency with accompanying funding.

We cannot allow the severe opioid crisis in this country to be highjacked by those who want to demonize Medicaid and its recipients. Medicaid expansion has almost certainly saved thousands of lives. Its rollback will have the opposite effect, restricting vital health care access to those affected by opioid use disorder, as well as millions of others. In 2016, 42,000 people in the United States died from opioid overdoses. Too many lives are at stake to waste time on vilifying Medicaid instead of implementing actual solutions.

Sincerely,

The George Consortium, a network of public health academics, experts, and practitioners around the United States, including:

Marice Ashe, JD, MPH, CEO of ChangeLab Solutions

Leo Beletsky, Professor of Law and Health Sciences, Northeastern University

Micah Berman, Ohio State University

Scott Burris, Professor of Law and Public Health, Temple University

Derek Carr, ChangeLab Solutions

Richard A. Daynard, Northeastern University School of Law

Linda Fentiman, Professor, Elisabeth Haub School of Law, Pace University

Robert I. Field, JD, MPH, PhD, Drexel University Kline School of Law and Dornsife School of Public Health

Lance Gable, Wayne State University School of Law

Rebecca L. Haffajee, JD, PhD, MPH, University of Michigan

Jennifer Lea Huer, Northeastern University School of Law, Center for Health Policy and Law

Peter D. Jacobson, Professor Emeritus of Health Law and Policy, University of Michigan School of Public Health

Nancy J. Kaufman, RN, MS, FAAN, President of Strategic Vision Group

Craig Konnoth, Associate Professor, University of Colorado Law School

Renee M. Landers, Professor of Law, Suffolk University

Wendy E. Parmet, Northeastern University School of Law

Elisabeth J. Ryan, JD, MPH, Northeastern University School of Law, Center for Health Policy and Law

Michael S. Sinha, MD, JD, MPH, Brigham & Women’s Hospital and Harvard Medical School

Cc: Members of the Senate Committee on Homeland Security & Governmental Affairs

 To contact Public Health Law Watch or the George Consortium, please reach out to Elisabeth Ryan at el.ryan@northeastern.edu or 617-373-8493.

Let's Get Fewer People to Die (from Northeastern Law Magazine)

Elisabeth Ryan, the head of Public Health Law Watch, wrote an essay about gun violence for the latest issue of the Northeastern Law Magazine.

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by Elisabeth Ryan

Guns were never a part of my life.  In the Massachusetts suburb where I grew up, my family did not go target shooting for sport and did not keep guns in the home for protection. The very idea of hunting was repugnant in our animal-loving household. In law school, my constitutional law classes never even mentioned the Second Amendment. My life was, in all tangible aspects, unaffected by guns.  But when I worked as a public defender, I represented people who commonly faced rampant violence in their lives and neighborhoods. For them, guns were often just part of reality. When I worked as counsel in the Massachusetts Executive Office of Public Safety and Security, overseeing state gun laws, regulations and policies brought me into contact with a population of individuals for whom guns were a central part of their lives, both tangibly and symbolically. 

I became aware that in the political world otherwise obsessed with firearms, recognition of gun violence as a public health issue was almost entirely absent.  So after years of practicing law, I went back to school and earned my MPH to study just that.

My mission now sounds deceptively simple: change the narrative around firearms from a bitterly partisan “us versus them” fight into a shared goal of getting fewer people to die.  To get closer to that goal, I think a few points are crucial to understand. 

First, the Second Amendment is not unlimited, contrary to what the pro-gun lobby espouses.  No right protected by the Constitution is unlimited.  And until the Supreme Court decided D.C. v. Heller in 2008, the law wasn’t even clear that the Second Amendment protected an individual right to possess a gun, as opposed to a collective right for militias.  In no way – now or ever –does the Second Amendment preclude stronger gun laws aimed at saving lives.

Second, the federal government essentially prohibits the Centers for Disease Control and Prevention (CDC) from conducting research on gun violence and that needs to change. In the 1990s, Congress deemed that a recent federally funded study that showed an association between guns in the home and increased homicide rates was anti-gun advocacy.  It subsequently stripped the CDC budget of the money previously allocated for firearms violence research and inserted a clause saying that no money “may be used to advocate or promote gun control." That clause has remained in every single federal budget since 1996.  The federal government needs to affirmatively fund research into a crisis that kills 30,000 people per year.  Refusing to do so devalues tens of thousands of lives.

Finally, some people will always value owning guns more than they value human lives and no amount of data or evidence will convince them otherwise.  But that doesn’t hold true for most gun owners.  Saving lives by preventing gun violence does not mean having to eschew gun ownership.  It can mean doing research, treating gun violence as a public health issue, increasing technological safety advances or tightening regulations on gun purchasing and storage.  It can start with laws, but also with friends, with gun dealers and with health care workers.  If we can all make the goal "let's get fewer people to die," I have no doubt that we can accomplish it.

The original essay published in the Winter 2018 issue of Northeastern University School of Law Magazine can be found here.

Involuntary Treatment for Substance Use Disorder: A Misguided Response to the Opioid Crisis [from Harvard Health Blog]

PHLW's Leo Beletsky, Elisabeth Ryan, and Wendy Parmet authored a piece this week on the Harvard Health Blog about why involuntary commitment for substance use disorder should not be touted as a tool in the opioid crisis.

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Recently, Massachusetts Governor Charlie Baker introduced “An Act Relative to Combatting Addiction, Accessing Treatment, Reducing Prescriptions, and Enhancing Prevention” (CARE Act) as part of a larger legislative package to tackle the state’s opioid crisis. The proposal would expand on the state’s existing involuntary commitment law, building on an already deeply-troubled system. Baker’s proposal is part of a misguided national trend to use involuntary commitment or other coercive treatment mechanisms to address the country’s opioid crisis.

The CARE Act and involuntary hold

Right now, Section 35 of Massachusetts General Law chapter 123 authorizes the state to involuntarily commit someone with an alcohol or substance use disorder for up to 90 days. The legal standards and procedures for commitment are broad; a police officer, physician, or family member of an individual whose substance use presents the “likelihood of serious harm” can petition the court.

Upon reviewing a petition, the court can issue a warrant for the arrest of the person with substance use disorder. The individual — who is not charged with a crime — is held pending an examination by a court-appointed clinician. The statute mandates that the determination proceed at a rapid pace, making it difficult to mount a meaningful defense.

The CARE Act proposes to further accelerate this process. The proposal would allow clinical professionals — including physicians, psychiatric nurses, psychologists, and social workers (or police officers when clinicians are not available) — to transport a person to a substance use treatment facility when the patient presents a likelihood of serious harm due to addiction and the patient will not agree to “voluntary treatment.” Upon determination by a physician that the failure to treat the person would create “a likelihood of serious harm,” the treatment facility has 72 hours to get the person to agree to voluntary treatment. If the person refuses, but the facility superintendent determines that discontinuing treatment would again cause “a likelihood of serious harm,” the facility must petition the court for involuntary treatment under the process outlined in Section 35.

For the full article, access it here.

Threats to Medicaid and Community Integration for People with Disabilities

By Mary Crossley

As we enter the second year of the Trump administration, Medicaid remains in the cross hairs of conservatives in Congress and the administration. The repeated efforts in 2017 to reduce the program’s funding and change its structure, however, revealed the breadth and depth of public support the program enjoys. People with disabilities protested, putting their bodies on the line to express their outrage over proposed cuts that would threaten their access to services that permit them to live in the community rather than institutions. Along with others’, their protests helped defeat Republican proposals in 2017, but similar battles likely lie ahead.

In the recently published “Community Integration of People with Disability: Can Olmstead Protect Against Retrenchment?”,  I explain how the Supreme Court’s holding in Olmstead v. L.C. ex rel. Zimring, combined with changes to Medicaid that permit states to devote funding to home- and community-based services (HCBS),  have contributed to meaningful state progress in enabling people with disabilities to live in the community. The article also considers the extent to which Olmstead could act as a check on a potential retrenchment of support for HCBS if states were to face severe reductions in federal funding for Medicaid. Although states proposing to cut their HCBS programs would likely raise the ADA’s “fundamental alteration” defense and assert that Olmstead recognizes the relevance of budgetary constraints to state decision making, I argue that states should not succeed with a fundamental alteration defense if disabled plaintiffs are suing to forestall cuts to existing HCBS programs and maintain the status quo. In short, Olmstead should provide a check against states’ backsliding in their support for integrating people with disabilities, at least in theory. But people with disabilities probably shouldn’t think that their protesting days are over just yet….

Read the article in Laws.

Center for Health Policy and Law Joins Amicus Brief in Correa v. Schoeck

Public Health Law Watch works in collaboration with the Northeastern University School of Law Center for Health Policy and Law.  The Center has signed on to an amicus brief, in support of the appellant-plaintiff, in the Massachusetts Supreme Judicial Court case of Correa v. Schoeck and Walgreens.  

The amicus brief is available here: Correa v. Schoeck, amicus brief

The issue in this case is "whether a pharmacy owes a duty of care to its customer to notify her physician that her insurer will not pay for her prescription medication without prior authorization."

Yarushka Correa was 19-year-old young woman who had recently been diagnosed with epilepsy after suffering a grand mal seizure.  Doctors placed her on Topamax, which effectively controlled her seizures.  However, her insurance company required that physicians obtain prior authorization before prescribing Topamax. Obtaining such authorization is a relatively routine paperwork process, yet it was never completed in this case. As a result, Walgreens would not dispense the medication and Yarushka was unable to fill her prescription for three months, despite going to Walgreens five times in an attempt to do so. In the normal course of business, and as promised to Yarushka and her mother, pharmacy employees contact the physician to notify of the need for prior authorization. No one at the pharmacy ever did that. Without her medication, Yarushka died after a grand mal seizure.

In the resulting wrongful death case, Walgreens argued that it owed no legal duty to Yarushka to inform her physician of the need for prior authorization before it would dispense her prescription. The Superior Court agreed and granted summary judgment to the pharmacy. Yarushka’s family appealed.

The amicus brief emphasizes that public policy dictates that pharmacy does, in fact, owe such a legal duty to patients.  When a pharmacy fails to inform a prescribing physician that prior authorization is required by an insurance company, it denies patients’ access to necessary medications, which can lead to harm and (as in this case) even death.  "Further, the pharmacy is not just the retail seller of a product, it is an essential part of the health care delivery system, far better equipped than the consumer, who is often vulnerable and in urgent need of medication, to understand and communicate to the physician about insurance payment denials for lack of [prior authorization]."

The case is scheduled for oral argument in the SJC on February 6, 2018.

Immigration and Health Care Under the Trump Administration [from Health Affairs Blog]

PHLW is back with this post by our own Wendy E. Parmet on the Health Affairs Blog.  The piece about the current state of immigration and health care comes out of her recent presentation at the Harvard Law School Petrie-Flom Center Sixth Annual Health Law Year in P/Review in December 2016.

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Immigration and Health Care Under the Trump Administration

by Wendy E. Parmet

Non-citizen immigrants are the canaries in the health care coal mine. Disproportionately poor, non-white, and non-English speaking, and without access to the franchise, they are among the most vulnerable groups in the United States. Consequently, they are often the first to experience the gaps, inefficiencies, and conflicts in our health care system. Meanwhile, anti-immigrant sentiment often spills into health policy debates, as was evident in 2009 when opponents of the bill that became the Affordable Care Act(ACA) focused their opposition on the erroneous claim that it would cover undocumented immigrants. It is therefore not surprising that the first year of the Trump administration, which has focused its domestic agenda on restricting immigration and repealing the ACA, has proven especially perilous for immigrants who need health care.

As a group, immigrants tend to be healthier than the native-born population. They are also far less likely to have insurance. In 2015, for example, 18 percent of lawfully present nonelderly adult immigrants, and 42 percent of undocumented immigrants were uninsured, compared to only 11 percent of United States citizens. Immigrants’ low insurance rate is partly due to the fact that they disproportionately work in sectors of the economy in which employer-sponsored insurance is uncommon. But the law also plays a significant role. Even before the Trump administration took office, immigrants faced an array of legal barriers to obtaining health insurance. Most importantly, the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PROWRA) prohibited undocumented immigrants from accessing most federally-funded insurance programs (including Medicaid, Medicare and Children’s Health Insurance Program (CHIP)). PRWORA also barred most authorized immigrants (except refugees) from benefiting from federally-funded programs for five years after obtaining legal status. And although the ACA made it easier for many documented immigrants to gain coverage, it left PROWRA in place. The ACA also limited participation in the exchanges to immigrants who are “lawfully present,” a category that the Obama administration decided did not include the approximately 800,000 young adults who participated in the Deferred Action for Childhood Arrivals (DACA) program. 

The Trump administration’s policies threaten to swell the number of uninsured immigrants, and deter those who have insurance from accessing needed care. For example, several of last year’s Republican proposals to repeal and replace the ACA included specific provisions to bar further classes of immigrants from purchasing insurance on the exchanges, even when they used their own money. Other proposals would have allowed states to deny Medicaid reimbursement for services rendered to eligible non-citizens prior to documentation of their immigration status. In addition, because immigrants tend to have lower incomes than the native-born population and are less likely to have employer-provided health insurance, they would have been disproportionately harmed by efforts to repeal the Medicaid expansion.

Read the entire piece on Health Affairs here: Immigration and Health Care Under the Trump Administration

Will Public Health Litigation Help to Solve the Opioid Crisis?

by Rebecca Haffajee

In this week’s issue of New England Journal of Medicine, Michelle Mello and I write about drug company liability for the opioid crisis. We analyze the history of litigation efforts against opioid manufacturers and distributors to hold these parties responsible, at least in part, for the epidemic. Early litigation brought by individuals harmed by prescription opioids against drug companies was minimally effective: most cases were dismissed early on and few settled. But these personal injury suits faced formidable company defenses -- such as that opioids were FDA-approved substances and that there were intervening causes (i.e., individuals not using the drugs as prescribed and doctors over-prescribing opioids) that contributed to the harm. However, in more recent years, mounting litigation lodged by governments may hold greater promise to succeed and reduce public health opioid-related harms, either through wins, settlements, or spillover effects. But let's be clear: litigation will not be a silver bullet to solving the crisis and shouldn't substitute for other public health-oriented policies and interventions. But lawsuits just might do some good here.  

Read more in our Perspective, entitled "Drug Companies' Liability for the Opioid Epidemic."

Minor Access to Prophylaxes in Massachusetts: STI Consent, the Mature Minor Rule, and the Definition of "Treatment"

By Jason Potter

The Massachusetts Joint Committee on Public Health is currently considering House and Senate bills to amend the Commonwealth’s emergency consent statute (Section 12F), which allows certain minors to self-consent to general medical care, and allows all minors to self-consent STI diagnosis and treatment. The bills would add the term “prevention” to the Commonwealth’s STI consent statute, thus allowing minors in Massachusetts to consent to STI diagnosis, treatment, and preventive care. Known as the “PrEP Bill,” S.1186 and H.3249 are sponsored by Senator Julian Cyr and Representative Jack Lewis, respectively. The senators are seeking to expand the language of the portion of Section 12F pertaining to STI-related care so minors may consent to HIV Pre-Exposure Prophylaxis (PrEP) and the human papillomavirus (HPV) vaccine. In my 2016 article PrEP and Our Youth: Implications in Law & Policy, I proposed this very change. On June 27, 2017, I testified before the Joint Committee in support of the PrEP Bill.

In its coverage of the hearing, the State House News Service declared that “[c]urrent law allows minors to consent to care without permission from a parent for treatment of sexually transmitted infections and HIV, but not for pre- or post-exposure treatments for HIV or for the human papillomavirus vaccine.” This suggestion that the PrEP Bill necessary to permit minors to self-consent to PrEP in the Commonwealth is not exactly true. If PrEP is considered a “treatment” under the Commonwealth’s common law “mature minor” rule and/or its STI consent statute, this would provide ample justification for furnishing PrEP to minors without parental consent. In this post, I argue that there is ample support for classifying PrEP, a prophylactic therapy, as “treatment” under either the common law rule or the Commonwealth’s STI consent statute. Therefore, while the PrEP Bill may provide clarification that preventive care is covered under the statute, it is not true that the bill is necessary to achieve that end.

In Massachusetts, notwithstanding statutory limitations, a minor with sufficient capacity to give informed consent may self-consent to medical care if the minor’s best interests are served by declining to seek parental consent. A court need not make the best interests determination; that assessment may be done by the provider. In Baird v. Attorney General, a 1977 case in the Massachusetts Supreme Judicial Court (SJC), the SJC concluded that “apart from statutory limitations . . . , where the best interests of a minor will be served by not notifying his or her parents of intended medical treatment and where the minor is capable of giving informed consent to that treatment, the mature minor rule applies in this Commonwealth.” The SJC then clearly stated that judicial intervention is not required, declaring that “[i]n such a case, . . .  judicial involvement is not required.” This common law rule, which is still good law in Massachusetts, is distinct from Section 12F. In fact, the Baird Court noted as much, stating that Section 12F “does not include all minors who might qualify in particular circumstances for application of a mature minor rule.” This language implies that the SJC intended the scope of the common law rule to be broader than the legislative rules.

Some community advocates in Massachusetts have indicated that the Baird Court’s mature minor rule is ineffective as applied to PrEP. According to advocates, the SJC’s specification of “treatment” (an undefined term) numerous times in the Baird holding leaves room for speculation as to whether PrEP is included. The argument goes that under a traditional definition of “treatment,” defined as the management and care of a patient to combat a disease, disorder, or condition, PrEP would not be included. PrEP is a prophylactic therapy prescribed to individuals who are not infected with the underlying disease, disorder, or condition and is, thus, distinct from treatment.

However, there are numerous reasons why prophylaxes are, indeed, treatments. First, the medication primarily used for PrEP is Truvada, an antiretroviral traditionally used as therapeutic HIV treatment but also applied for preventive purposes. The medication at the core of PrEP is principally a treatment drug. Second, excluding preventive therapies from the definition of treatment is logically inconsistent with the Baird Court’s intent to craft a broad rule. Such an implication would essentially mean that, in the ambit of STI-related care, the Commonwealth’s mature minor rule is functionally narrower than the STI-related language in Section 12F. Both specify treatment, but Section 12F also pertains to diagnosis (the common law rule does not), and further, the statute does not require the additional best interests consideration required by the Baird rule. In other words, a narrow reading of “treatment” in Baird that excludes prevention would mean that the common law rule is no more permissive but is, in fact, more limited than the statutory rule. This runs counter to the Baird Court’s suggestion that its mature minor rule should apply to circumstances outside the scope of the consent statute.

But more importantly, an interpretation of the term “treatment” that excludes PrEP ignores the fact that a minor may already self-consent under the common law rule (and Section 12F, for that matter) to HIV post-exposure prophylaxis (PEP). PEP is a combination of Truvada and another ARV administered for thirty days and is highly successful at preventing seroconversion if furnished within a 72-hour window of possible exposure to HIV. PEP is widely considered a “treatment.” After all, PEP treats the condition of exposure to HIV in those at significant risk of HIV infection. PrEP, too, is indicated for those “very high risk of coming in contact with HIV,” as these individuals sometimes have sex without a condom “when they have sex with a person who has HIV infection,” according to the CDC. Thus, the clinical profile of PrEP contemplates that the patient has already engaged in conduct that may have exposed him or her to HIV. Because both PEP and PrEP are considered appropriate for those who may have been exposed to HIV, the two therapies are so closely related that they are indistinguishable. The two therapies even share coding; recommended coding for both PrEP and PEP are “contact with and (suspected) exposure” to HIV (ICD-10, Z20.6). But the similarities do not end there. Both are termed prophylaxes. Both are “event driven” treatments. Both involve the same high-risk group. Both use the same drugs and have similar risks and benefits. (In fact, PEP may involve more risk to the minor because another ARV is added to the therapy.) Thus, since a minor may consent to PEP as treatment under the Baird mature minor rule, there is no reasonable argument that the law would exclude PrEP. In fact, in one of the only PrEP-related court decisions in the world, an Irish high court recently reached the same conclusion about the indistinguishability of PrEP and PEP, finding that any differences between the two “are differences without relevant distinctions.” [p. 31]. The indistinguishability of PrEP and PEP, in part, led the High Court of Justice to conclude that PrEP is a “treatment” under NHS England’s rules. [pp. 35-37].

Nearly all of these arguments that PrEP is a treatment apply with equal force to the STI consent statute, which is limited to “diagnosis and treatment.” But a consideration of whether PrEP is a treatment isn’t even necessary under the plain language the Section 12F. All that’s necessary is consideration of whether PrEP is related to diagnosis or treatment of HIV, for the STI consent statute states that a minor who believes himself to have or come into contact with an STI may “only consent to care which relates to the diagnosis or treatment of such disease.” There is no ambiguity here. PrEP is surely a type of care related to the treatment of HIV. PrEP is prescribed so the patient doesn’t need treatment in the first place. Not needing something is related to something. Since a prophylaxis prevents the need for treatment of infection, it relates to treatment of infection. Thus, I strongly aver that PrEP therapy (and the HPV vaccine, for that matter) may be prescribed under the existing STI consent statute pursuant to a plain reading of the statute.  

Therefore, the Commonwealth’s mature minor rule and its STI consent statute are each an independent basis for furnishing PrEP without parental consent. Providers in the Commonwealth should be especially confident furnish PrEP to self-consenting minors under the STI consent statute because it doesn’t even require taking the risk that a court may not consider PrEP a “treatment” if the issue was litigated. Again, all the STI consent statute requires is that the care is related to treatment of HIV.

Thus, while I support the PrEP Bill insofar as it eliminates any uncertainty in current law, I am not doing so because the PrEP Bill is necessary for minors to consent to PrEP in the Commonwealth. It is not.