Category: Blog

This week, the United States Surgeon General issued an advisory, urging more Americans to begin carrying the opioid overdose-reversing drug, naloxone. The last time the Surgeon General issued such an advisory to the American public was more than a decade ago, focusing on the hazards of alcohol consumption during pregnancy—perhaps a signal that the opioid crisis is worse than the public recognizes.

Narcan, one of the more popular brand name drugs, temporarily reduces the effects of an opioid overdose and can restore normal breathing to a person suspected to have overdosed. It comes in the form of a nasal spray, making it simple for untrained users to administer. Now, Narcan is widely available in pharmacies across the United States, including CVS and Walgreens. Though only some states permit the sale of Narcan over-the-counter, most now even permit family members of drug users to receive Narcan without a prescription at pharmacies.

As nearly 91 Americans die each day from an opioid overdose, President Donald Trump has declared the opioid crisis a public health emergency. However, the widespread availability of Narcan, especially in states where it is available over-the-counter, presents interesting legal questions. Access to Narcan was limited until state legislatures provided specific statutory protections for nonmedical personnel to possess and administer the drug to persons suspected of an overdose. This practice, called “third party prescribing,” permits physicians and medical personnel to dispense Narcan, or other similar drugs, to a person other than the one at risk for overdose.

As regulation of the medical profession typically falls to the states themselves, a physician generally can legally prescribe a drug to his patient when it is (1) in good faith, (2) in the usual course of professional practice, and (3) for a legitimate medical purpose. Nevertheless, in the absence of federal action to combat the opioid crisis, states have enacted legislation that increases access to these potentially life-saving opioid overdose-reducing drugs. Such legislation reduces liability for the prescribers, dispensers, and administrators, thereby attempting to increase the availability to Narcan to affected consumers who may fear the stigma of requesting their own prescription, or who may lack the funds or health insurance to access Narcan themselves. Fortunately, the drug has no abuse potential, but still requires individuals to seek medical attention immediately following the administration of the drug. Since Narcan is only a temporary solution, the symptoms of an overdose may return and require immediate medical attention.

As more states attempt to reconcile with the widespread opioid epidemic, the federal government needs to take a firmer stand. By enacting federal legislation to provide Narcan and similar drugs over-the-counter, the government can increase the availability of the drug and prevent opioid-related deaths. The federal government can also permit community distribution, which often involves supplying the drugs to addicts without cost, as well as require federal assistance programs to cover the costs of Narcan. Overall, the number of synthetic opioid-related deaths has reached 200,000, and the federal government must act to combat this epidemic—sooner rather than later.

Last Wednesday, the House of Representatives passed a bill that aims to give terminally ill patients the “right-to-try” drug treatments that have not yet been approved by the Food and Drug Administration (FDA). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, introduced as H.R. 5247, received a majority vote of 267 to 149. The previous week, the bill failed to receive the required two-thirds majority vote in the House to proceed. As reintroduced, the bill required only a simple majority vote to pass.

During debate on the House floor Wednesday, Representative Frank Pallone Jr. (D-N.J.), the top Democrat on the House Energy and Commerce Committee, asserted that allowing patients to access investigational treatments that have only completed a phase 1 clinical trial would expose patients to treatments with little or no efficacy data. The American Cancer Society Cancer Action Network (ACS CAN), along with over 75 organizations representing millions of patients, expressed concern and opposition to the bill, saying not only would it remove FDA approval and consultation, but it would also fail to increase access to promising therapies since the bill does not address primary barriers to access to investigational therapies. ACS CAN further stressed opposition since the proposed bill would remove FDA’s role in consultation on dosing, route of administration, dosing schedule, and other safety measures under the current program.

Proponents of the legislation, such as House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), note that 38 states have right-to-try legislation and point to additional monetary federal support. Supporters maintain that the bill strikes the right balance for patients and their safety, arguing that those with a terminal illness should have every tool at their disposal. However, critics of the legislation fear it could lead to a slippery slope of bypassing FDA regulations. Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania, said the bill probably would not increase access to investigational drugs beyond what the FDA already allows. According to Professor Lynch, “[t]he bigger challenge is this attack on the FDA’s very reason for existence.”

The bill will now move back to the Senate for approval. Last August, the Senate approved similar legislation. If approved, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 would introduce legislation across state lines. Whether the federal bill will increase access to unapproved treatments for terminal patients remains an open question.

 

Ambulance rides in the U.S. are expensive. The most recent data from the U.S. Government Accountability Office revealed they can range from $224 to $2,204. Recent figures suggest ambulance bills can be as high as $3,500 and depending on your insurance plan, you could be footing the entire bill. For some patients, even when experiencing a non-life-threatening illness, calling an ambulance is the only option because they lack transportation. To avoid these high costs, people are turning to ride-sharing services like Uber and Lyft to get to the hospital for a fraction of the price, according to a new unpublished study. This option might actually be beneficial in non-life-threatening situations. However, individuals who use ride-sharing services for serious emergencies simply to save money could raise serious liability concerns and leave drivers asking themselves whether this is in their job description.

Uber and Lyft discourage drivers from transporting individuals to the hospital. In an attempt to shift liability away from the company, Uber has published statements such as “Uber is not a substitute for law enforcement or medical professionals. In the event of any medical emergency, we always encourage people to call 911.” But this is easier said than done when an individual gets into the car and time is of the essence. While some drivers consider these trips as good deeds, others simply feel obligated to transport these individuals to the hospital. The bottom line is ride-sharing drivers are unequipped to deal with emergency health situations. Ambulances are equipped with comprehensive medical technology and life-saving devices, whereas even the most hospitable Uber drivers may offer candy and a phone charger. Even when a customer gets into a Lyft seemingly healthy, drivers are still taking on the risk if the customer’s condition takes a turn for the worst before reaching the hospital. In one instance, a woman whose destination was the hospital got into the car seemingly healthy, only to request the driver to pull over minutes into the ride to get sick on the side of the road.

So, what happens if a customer’s condition worsens as a result of opting for an Uber or Lyft over an ambulance? Attorneys argue that it is unlikely someone would bring suit against an Uber driver for not providing adequate medical treatment because fault would be difficult to prove, and the driver may not be equipped to pay a large settlement or damages. In addition, it is difficult to sue the ride-sharing company directly through employer liability because drivers are hired as independent contractors, so the company is able to shift liability away from them. However, attorneys are recently taking a different approach against these companies, arguing that the drivers were acting as the company’s agent, and therefore the company cannot avoid liability. Attorneys argue that drivers really don’t have control over their individual ride-sharing business. Rather, ride-sharing companies control fares and impose guidelines for how drivers should conduct business before, during, and after rides. If the drivers do not conform, they receive warnings and ultimately risk termination. Since ride-sharing companies do not want the issue of whether drivers are independent contractors or agents decided in court, they settle with the customers that bring suit.

Despite arguments against calling an Uber over 911 in the event of a life-threatening emergency, ride-sharing services are still finding avenues to enter the health care stage. Uber recently launched a new initiative, Uber Health, designed to increase patient access to reliable transportation to doctor appointments. Missed appointments are unfortunately common in the U.S., with 3.6 million Americans missing or delaying appointments due to a lack of reliable transportation. These missed appointments cost the health care system $150 billion annually. The Uber Health dashboard allows healthcare providers to schedule rides for their patients to and from appointments. In addition, the platform is completely HIPPA-compliant, so patient confidentiality is preserved. This progressive move is helpful in the midst of increasing health care cost, but the question still remains whether calling an Uber over 911 is really worth the discount.

On February 27, 2018, Vice President Pence predicted that abortion could become illegal within “our time.” While attending a luncheon hosted by the Susan B. Anthony List & Life Institute, an anti-abortion institute, Pence hypothesized:“[i]f all of us do all we can, we can once again, in our time, restore the sanctity of life to the center of American law.”

Given the controversial nature of abortion in the United States, Pence’s comment normally would not amount to any concern over the legality of abortion. However, speculations of such policies, specifically the Supreme Court overturning Roe v. Wade, have been circulating since the 2016 campaign. During the 2016 campaign, then-candidate Donald Trump was asked if there should be a punishment for women who chose to have abortions, he responded, “there has to be some form of punishment… there has to be some form.” More recently, these concerns of abandoning Roe arose during Justice Gorsuch’s nomination. Although now-Justice Gorsuch said he would “have walked out the door” if President Trump had asked him to overturn Roe, Vice President Pence’s comment is a reminder that in the current political state anti-abortion legislation may become an inevitable reality.

In Roe, the landmark case in abortion rights, the Supreme Court held that a woman has the right to have an abortion. Although Roe and its subsequent case law have placed restrictions on when and how a woman can get an abortion, today, the choice still remains with the woman to decide if she wants an abortion. Roe and the legalization of abortion were important for more than just the right to choose. The legalization of abortion also allows states to regulate the safety of abortion procedures themselves so long as they do not impose an undue burden, or substantial obstacle, on a woman trying to get an abortion.

Keeping abortion legal keeps abortion safe. States have legitimate interests in the health and safety of pregnant women, as well as the potential life of the unborn child, and thus are able to regulate abortion procedures. Between the criminalization of abortion and Roe, it is estimated that up to 1.2 million illegal abortions were performed per year in the United States. During this period, women with means had several options for an illegal abortion: leave the country and have a medical abortion abroad, or find a physician willing to perform an abortion. And even in these cases, safety was not guaranteed. Both options were expensive and largely inaccessible to women without means. Women who could not afford to pay off a doctor or leave the country resorted to back-alley procedures and home remedies, such as inserting knitting needles and coat hangers into their vaginas. These methods often resulted in serious injury, infection, and death.

Due to medical advances, abortions have become significantly safer since its inception thousands of years ago. In fact, Justice Ginsburg discussed how safe abortion now is in her concurrence in Whole Woman’s Health v. Hellerstedt. Today, states may impose reasonable standards on facilities that perform abortions to protect the safety and wellbeing of the patients. Medical abortions performed in hospitals and clinics have a 0.5% incidence of major complications. Moreover, in 2013, out of the nearly one million abortions performed, only four women died of complications arising from abortion.

Although mortality and incidence of injury related to abortion has decreased in the U.S., globally, between 4.7% and 13.2% of maternal deaths can still be contributed to “unsafe abortion.” The World Health Organization defines unsafe abortion as “when a pregnancy is terminated either by persons lacking the necessary skills or in an environment that does not conform to minimal medical standards, or both.” The WHO cites the legality and availability of abortion as two of the major barriers for women to obtain a safe abortion.

If Vice President Pence is correct, and abortion becomes illegal within “our time,” the need for abortions will not cease, the ability to obtain an abortion will not end, and the number of abortions performed per year will not be zero. What will change is the access to safe abortions. “The abortions will continue regardless of whether it’s legal or not legal – as it always has.”

Mental illness continues to be stigmatized in the United States, making it difficult for people to discuss and to pursue help. Like mental health, incarceration is a branding topic that often carries with it negative connotations and judgments. Both of these matters are significant and deserve research, awareness, and reform alone; however, the issue of mental health in prisons is one that encompasses both of these issues and must be addressed. The lack of access to services for incarcerated individuals is devastating.

One of the main objectives of incarceration is isolation and separation from the outside world. Because of this, the institutions must provide their inmates with everything essential like food, water, bedding, etc. At what point does the law draw the line between what is essential and what is not? What does this mean for mental health?

The U.S. has the highest rate of adult incarceration among the developed countries, with 2.2 million currently in jails and prisons. Those with mental disorders have been increasingly imprisoned over the last thirty years, most likely due to the deinstitutionalization of the state mental health system. Correctional institutions have become de facto state hospitals, with more seriously and persistently mentally ill inmates in prisons than in all state hospitals in the United States. In cases like Ruiz v. Estelle, U.S. courts have clearly established that prisoners have a right to receive medical and mental health care.

In order to meet this need, it is important to examine options and solutions inside the prisons. Often, state correctional departments have agreements with state departments of mental health to have professionals come into the prisons and provide acute care. Having these mental health professionals come to prison helps address many issues including the lack of ability to transport inmates to outside facilities, understaffed and under trained prison personnel, and lack of resources in general.

Suicide is the third leading cause of death in U.S. state and federal prisons. Suicide-prevention programs in prisons are of increasing importance to mental health professionals, correctional administrators, health care providers, legislators, attorneys, and others as they seek to rehabilitate offenders and avoid the multi-million dollar lawsuits that result from inmate suicides. Suicide prevention efforts must extend beyond the mental health staff of prison facilities, and begin to include guards, administrators, and custodial staffs.

Another important measure is a change of perspective on punishment as a whole. There has been an increase in the use of diversion programs such as mental health and drug courts across the country. These courts work with mental health and substance abuse treatment providers to assist those who struggle with these problems. In order to participate in this treatment alternative, a person must first plead guilty to a crime and be subject to incarceration. Although these alternative routes have many advantages and a great focus, evaluations of mental health and drug courts have shown questionable success and significant challenges.

Another alternative is the use of pre-booking diversion. A pre-booking diversion plan is is one that identifies low-level offenders and redirects them from jail and prosecution by providing linkages to community-based treatment and support services. This alternative requires the efforts of both a law enforcement and social services. When possible, individuals who do come in contact with police should be diverted to other options like treatment before they are ever faced with arrests, charges, and sent to the police station for booking.

Overall, the need for prison-based mental health treatment is profound. It is important we focus our efforts inside the prisons with the staff, health care providers, and inmates in order to create a safer environment. It is also important we move away from the system of punishment, and instead consider alternatives to incarceration in order to rehabilitate and prepare these individuals for life in the community.

On January 18^th, 2018 the Department of Health and Human Services answered the President’s May 4^th executive order “Promoting Free Speech and Religious Liberty” by creating the Conscience and Religious Freedom Division (“CRF Division”) in the Office for Civil Rights (“OCR”). The CRF Division seeks to enforce existing federal statutes that protect health care providers from discrimination if they refuse to provide or refer medical services that run contrary to their religious beliefs. HHS then followed up with a proposed rule requiring health care organizations to post notices of religious freedom protections on job applications and employee manuals. The proposed rule applies to health care facilities that receive federal funding. Collectively, these initiatives affect more than 745,000 health care facilities and are estimated to cost $312.3 million dollars in the first year. Supporters believe this is a monumental step in promoting long over-due religious freedom protection. However, opponents are concerned about how extensive these protections will be, and whether they will negatively impact patients’ access to critical health care.

The religious freedom statutes upon which HHS’s proposed rule is based, collectively referred to as “Federal health care conscience and associated anti-discrimination laws,” largely impact access to medical services for women. For example, the Weldon Act provides “protections for health care entities and individuals who object to furthering or participating in abortion” and the Coats-Snow Amendment provides “conscience protections related to abortion, sterilization and certain other health services.” HHS argues that while these laws and numerous others are in fact codified, they are not being enforced to the necessary extent. Therefore, the CFR Division is tasked with reviewing the growing number of complaints filed in the OCR. Since President Trump was elected, the OCR received thirty-four complaints of conscience violations while the Obama administration received ten. The complaints allege discriminatory employment practices ranging from compelling nurses to either provide abortion referrals or resign to not hiring an individual based on religious beliefs conflicting with hospital policies. Pursuant to the complaints, the CRF Division will conduct compliance reviews, investigations, and audits to ensure that health care providers are compliant with federal legislation.

How do these initiatives impact patients? While they focus on protecting health care providers, the Department of Health and Human Services’ proposed rule reveals how patients   can benefit from increasing religious freedom protections. These patient-centered benefits include having the ability to choose a healthcare provider who shares their “deepest convictions” and to “speak frankly about their own convictions that concern questions touching upon life and death.” However, critics argue that HHS’s initiatives are inherently not patient-centered because they go against the fundamental idea that health care providers are supposed to put their patients’ interests before their personal beliefs. For example, in a 2000 case, a New Jersey woman suffering from pregnancy complications was “standing in a pool of blood” and required an emergency C-section. After a nurse scrubbing in realized the C-section would terminate the pregnancy, she objected to continuing assistance on religious grounds and delayed the procedure. After refusing a reassignment offer to the newborn ICU from the hospital, the nurse was terminated. She sued the hospital and the court ruled in favor of the hospital. While the CRF Division was enacted to help protect nurses and other health care workers in situations like this moving forward, the fact still remains that patients risk receiving delayed care or no care at all.

The strong support behind protecting religious freedom also poses a concern when vulnerable populations like LGTB patients cannot access the care they need. OCR Director Roger Severino expressed during the CRF Division’s press conference that “a nation that respects conscience rights is a more diverse nation, it is a more free nation, and is a more just nation.” However, while HHS focuses its efforts on protecting religious freedom, it is risking promoting discrimination against vulnerable populations. For example, one Catholic hospital blocked a doctor from performing a hysterectomy on a transitioning transgender patient. It is unlikely that HHS will promote similar conscience protections for LGBT patients during the current administration. This is evidenced by a statement from Severino, who said “on the basis of religious teachings, moral reasoning, scientific evidence, and medical experience, many have strong grounds to hold that one’s sex is an immutable characteristic.” President Trump’s Justice Department also holds similar beliefs, stating said “sexual orientation is not a protected category” in regards to discrimination protections.

At this point, it is unclear the full impact these initiatives will have on access to health care for women and vulnerable populations like LGBT patients. However, one thing is clear: forcing doctors to refrain from care conflicts with their moral convictions the same way forcing doctors to provide it does. Therefore, a balancing test is necessary to ensure that while peoples’ religious convictions are being respected, patients’ access to care is not compromised as a result. The National Health Law Program argues that given the small percentage of people filing complaints with the OCR, the Trump Administration is creating solutions like the CRF Division to problems that do not really exist. However, if complaints continue to grow and cannot be solved by non-litigious means, the ultimate determination on whether religious freedom protections reach as far as HHS intends will come from adjudication in federal courts.