A License to Discriminate in Health Settings

In a recent federal court case, Religious Sisters of Mercy v. Azar (2021), a coalition of healthcare entities affiliated with the Catholic Church attacked a nondiscrimination provision under Section 1557 of the Patient Protection and Affordable Care Act (PPACA). The U.S. District Court in North Dakota granted a permanent injunction that enjoins the US Department of Health and Human Services (HHS) from enforcing Section 1557 of the PPACA. This injunction also prevents the HHS from withholding federal funding to religiously affiliated providers and insurers who deny transition services. The Plaintiff in this case originally sought an exemption from the anti-discriminatory laws that compelled them to perform and provide coverage for gender transitions and abortions. The Court, however, chose not to rule on the abortion claims. Although this ruling granted protection of religious freedoms under the First Amendment, it also allows healthcare providers impose their religious beliefs onto others and deny essential transgender health services. The implications of this ruling could lead to a broader chipping away of protections for healthcare services that are perceived as “unconscionable” by religiously-affiliated providers and insurers.

Section 1557 of the Patient Protection and Affordable Care Act states that patients shall not, “be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance.” The congressional intent of this provision was to create an all-encompassing healthcare antidiscrimination statute. This was demonstrated through the expansion of existing civil rights laws, specifically the expansion of Title IX, which had only prohibited sex discrimination in federally-funded school activities. Other important civil rights laws that the provision expanded include Title VI (preventing race, color and national origin discrimination), Section 504 (preventing disability discrimination) and the Age Discrimination in Employment Act (preventing age discrimination).

Religiously-affiliated hospitals make up a large portion of the of the hospital’s patients have access to in the United States. In 2016, MergerWatch and Maidson Healthcare Advisors released a report showing that 14.5% of all acute care hospital in the U.S. were Catholic affiliated. The report also found that 46 of these Catholic affiliated hospitals are the sole short-term, acute health care resource for many patients living in specific geographical regions. As a result of this ruling, patients living in these regions who lack access to adequate transportation, have now lost access to transition services.

Should religious protections under the First Amendment extend to health programs at the expense of equitable health care access? While some could argue that those in need of transgender health services can just go to a non-religiously-affiliated hospital, many of these individuals are limited to the hospitals within their geographical region. As other First Amendment lawsuits similar to Religious Sisters v. Mercy are filed, courts will have to determine if granting relief  to religiously-affiliated health entities limits the protections of Section 1557 under the guise of religious freedom.           

Leave a Comment

Filed under Uncategorized

Are Abortion Pill In-Person Requirements During COVID-19 Unduly Burdensome? SCOTUS Says No.

Medication abortion, commonly referred to as the abortion pill, is a safe and effective way to terminate an early pregnancy and has been available in the United States for the past 20 years. The abortion pill is as safe and effective as the surgical procedure, but it can be administered in the comfort of one’s home. Abortion via medication requires the patient take two different drugs: mifepristone and misoprostol. Mifepristone is taken first and blocks the body’s progesterone and stops the pregnancy from progressing. Next, Misoprostol causes the uterus to empty. Individuals can obtain and use the abortion pill up to 77 days or 11 weeks after the date of their last period, although the effectiveness depends on how far along they are into their pregnancy.

The FDA first approved mifepristone in 2000. Mifepristone is a synthetic steroid that is also used to treat hyperglycemia in patients with Cushing’s syndrome. In the United States,  the use of mifepristone for abortion is highly regulated by the FDA through a set of rules known as the risk evaluation and mitigation strategy (REMS), despite evidence of its safety and efficacy. Among other restrictions, the REMS limits the distribution settings of mifepristone, not misoprostol, to clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber. This is referred to as the in-person requirement. Mifepristone, when used to end pregnancy, is the only FDA-approved drug required to be dispensed in clinical settings while permitting patients to self-administer at home. Furthermore, the FDA permits patients taking mifepristone for reasons other than abortion to receive the drug through the mail in much higher doses and quantities.

On January 31, 2020, the Secretary of Health and Human services declared a public health emergency pursuant to the Public Health Service Act. Subsequent regulatory guidance focused on allowing patients to access healthcare they need from their home, without worrying about putting themselves or others at risk during the COVID-19 outbreak. This included waivers in recognition of the health risks associated with patient travel to medical facilities, even invoking the use of the “telemedicine exception” in the Controlled Substances Act, which permits practitioners to forgo an in-person evaluation of a patient before prescribing certain controlled substances, including opioids, permitting them instead to rely on telemedicine to assess a patient before issuing a prescription. In response to this flurry of telehealth exceptions, abortion providers challenged the in-person requirement still restricting mifepristone. The US District Court for the District of Maryland granted a preliminary injunction enjoining the FDA from enforcing, threating to enforce, or otherwise applying the in-person requirements for Mifepristone.

On January 12, 2021, the Supreme Court issued a brief and unsigned opinion that overturned the District Court’s decision and reinstated the federal requirement that women seeking to end their pregnancies using the abortion pill pick up their medications in person. Chief Justice Roberts, the only member of the majority to write an opinion, explained that this case was decided on judicial deference and allowed the FDA experts to use their statutorily provided discretion. According to Chief Justice Roberts, the issue was not whether the regulation placed an undue burden on women seeking abortions during the COVID-19 pandemic but whether the District Court properly enjoined the FDA from enforcing the in-person requirement. Despite the Court’s insistence that the issue presented did not concern the in-person restriction itself, the effects of this ruling on women seeking abortions is catastrophic.

Due to the vastly limited clinic options and already tight window for obtaining an abortion pill prescription, the FDA’s in-person requirement for Mifepristone places an unnecessary and undue burden on the right to abortion as established in Planned Parenthood v. Casey. In her dissenting opinion, Justice Sotomayor stated that this ruling “singles out abortion for more onerous treatment than other medical procedures that carry similar or greater risks” and “it imposes an unnecessary, irrational and unjustifiable undue burden on women seeking to exercise their right to choose.” The Supreme Court’s ruling brings into question what qualifies as an undue burden under the current judicial framework, and if any obstacle will prevail in arguments before the current majority.

Please contact Managing Editor for Sources.

Leave a Comment

Filed under Uncategorized

When a Pandemic Meets an Epidemic: The Opioid Crisis during COVID-19.

In the last year, the COVID-19 pandemic has collided with the opioid epidemic creating an influx of relapses, overdoses, and deaths. Over 20 million people in the United States have a substance use disorder. As of September 2020, thirty states reported an increase in opioid fatalities since the pandemic started in early 2020. While the overwhelming presence of anxiety, grief, and depression caused by or exacerbated by the pandemic significantly contributed to these numbers, the ongoing isolation continues to prevent individuals suffering from addiction from accessing support systems, hospitals, treatment centers, and other sources of help. Whether it is the fear of contracting the virus from a physician’s office or not having anyone nearby to recognize a dangerous situation, the pandemic has become a severe impediment to the opioid crisis. Luckily, American health organizations are increasingly aware of this rise in substance use disorder and are acting.

In July 2020, the FDA took necessary steps to make naloxone, a medication that can help reverse opioid overdose to prevent death, accessible to the community. To do this, the FDA required opioid manufactures to update package inserts to include recommendations about naloxone and its benefits. This recommendation encourages providers to discuss naloxone with all patients when starting or renewing an opioid treatment. It also urges providers to assess each patient’s need for a naloxone prescription. The FDA plans to implement these changes early this year.

Following agency action, in December 2020, the American Medical Association (AMA) provided recommendations to help states and policymakers support patients with opioid use disorder during the pandemic. These recommendations include ensuring access to care for patients with an opioid use disorder, protecting patients with pain, and utilizing harm reduction efforts to better prevent overdose and the spread of infectious disease. As a result, states like Washington, New Jersey, and Ohio are utilizing curbside and doorstep deliveries of methadone and buprenorphine for quarantined or isolated individuals because of COVID-19 and those in the at-risk population. Additionally, organizations like the American Academy of Physical Medical & Rehabilitation provided COVID-19 specific recommendations and considerations for physicians treating patients with chronic pain.

Increased state and agency responses also influenced the federal government to take action for patients suffering from substance use disorder. In January 2021, the Department of Health and Human Services issued a decision to allow physicians to “prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder.” This decision allows physicians to work with patients and provide care without worrying about authorization barriers and a strict regulatory regime. This cancellation of the waiver requirement effectively reduces the detrimental stigma and health disparities in accessing treatment. It nevertheless is important to acknowledge the systemic racial and socioeconomic inequities that still plague America’s health care system.

The repercussions of the collision between the opioid epidemic and the COVID-19 pandemic are only starting to show. The increased need for addiction treatment combined with the decreased access to treatment options presents a detrimental problem in the United States. Policy and lawmakers must continue to analyze and reevaluate how organizations delivery health care to its stakeholders, including adapting to the use of telehealth and continuing the use of regulatory waivers. People with substance use disorder should not have to battle addiction alone during and after the pandemic.

Leave a Comment

Filed under Uncategorized

Vaccine Bartering: Israel’s real-world evidence exchange with Pfizer

In the global race to secure COVID-19 vaccines, Israel, the 100th most populous country behind Papua New Guinea and Serbia, is the world leader in COVID-19 vaccine doses administered per capita. In a span of just 7 weeks, Israel, to date, has administered a total of 5.3 million doses, inoculated nearly approximately 30% of its total population, and 80% of citizens 60 years of age and older. In context, Israel has administered 58.9 doses per 100 residents, far exceeding the UK’s 16.5 doses and the US’s 10.6 doses. Which begs the question, how exactly has Israel beat out these bigger countries in the race to secure the coveted COVID-19 vaccine supply?

Israel struck a unique deal with Pfizer – vaccines for health data. On January 7, 2021, it was announced that Israel made an agreement with Pfizer to expedite deliveries of its COVID-19 vaccines so that all citizens over 16 years of age can be inoculated by the end of March 2021 in return for the health data of citizens taking part in the vaccination program. Formally named the “Real-World Epidemiological Evidence Collaboration Agreement,” the deal describes that the Project’s objective is to “measure and analyze epidemiological data arising from the Product [Pfizer-manufactured vaccines] rollout, to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel.” As part of this collaboration, the agreement stipulates that Israel’s Ministry of Health will “use its best efforts to ensure timely reporting [of Project Data] to Pfizer” and “will assure rapid distribution, deployment, and use of the Product.”  In exchange, the Ministry is “relying on receipt of Product doses […] and on the product delivery rate by Pfizer to allow maintaining vaccination rate sufficient to achieving herd immunity and enough data as soon as possible.” Beyond this, however, the exact bargain between Israel and Pfizer is unclear.

As one can imagine, this agreement has instigated fierce debate in Israel among data privacy experts, researchers, and citizens weighing the potential benefits of having highly valuable real-world evidence on vaccination efficacy against the potential abuse of millions of personal medical records. The only solace the agreement offers is in its limited definition of “Project Data” (defined as any de-identified data provided by the Ministry of Health to Pfizer in the framework of the Project) and a 7 item list of the governing regulations concerning data use. Understandably, critics question why the agreement made no mention of what measures Pfizer is taking to keep the data secure or that Pfizer’s use of the data is limited to studying the effects of the COVID-19 vaccine.

Despite engaging in this novel arrangement, Israel is not new to the big data scene. Israeli health plans utilize a universal electronic medical record system and cover about 98% of the population. Although operating independently, Israel’s four HMOs and their affiliated hospitals have for the past two decades used the same electronic medical records platform, with access to patient records available at each point of care as needed. To Pfizer’s delight, this has resulted in a wealth of data about patients, conditions, and treatments. But Israel’s privacy and data protection laws, the same named in the agreement, fall behind those of the surrounding EU, allowing for much more latitude in the use and disclosure of its citizens’ data.

Although we cannot predict if and how Israeli’s health data will be used by Pfizer, or if a precedent has been set encouraging less-wealthy countries to trade citizen privacy for pharmaceuticals, we do know that Israel’s rapid vaccination roll-out (as a result of this agreement) appears to be working – Cases and hospital admissions in Israel are falling steeply among vaccinated age groups. Data collected by Israel’s Ministry of Health show that there was a 41% drop in confirmed COVID-19 infections in that age group and a 31% drop in hospitalizations from mid-January to early February.

Leave a Comment

Filed under Uncategorized

Critical Medical Infrastructure and the Right to Repair: H.R. 7956 and Beyond

In November 2020, Massachusetts approved a ballot measure expanding upon a 2012 “right to repair” law in the state. This law required car manufacturers to let consumers access data on repairs to their vehicles. The amendment went further allowing manufacturers until 2022 to install a standard open data platform which will give independent mechanics access to data typically sent to a remote server.

This win comes as the right to repair movement is gaining ground more widely. The movement backs various legislative initiatives that would prohibit the types of restrictions manufacturers put on product repair; limiting who is permitted to repair things and how available parts are is a common tactic used by manufacturers. From a pro-consumer perspective, repair industry interest groups argue that companies owe information, access, and reparable products to the people supporting them.

“[R]egular consumers should be able to repair the products they’ve purchased[.]” This is the lobbyist stance taken by the movement and consumer interest groups alike––consumer groups like iFixit, a website that makes electronic repair kits accessible for all. Lately, the movement has its sight set on medical equipment: iFixit recently released a comprehensive medical equipment service database in order to assist biomedical engineering technicians in repairing everything from imaging equipment to ventilators.

Making repair files available to repair technicians in hospitals has not been more of a necessary public good than right now. While American medical device makers drastically increased production of ventilators in the summer of 2020 to combat COVID-19 shortages, a problem persists: there aren’t enough specialists to operate, maintain, and monitor these complex machines, especially in rural areas. Additionally, the machines that were mass-produced to equip the Strategic National Stockpile at the height of the crisis were not built to last and require frequent maintenance.

Large device manufacturers shared the design specification “blueprints” for some of their ventilation devices, but this good faith act doesn’t go far enough. In the case of Medtronic, the manufacturer of the Puritan Bennett 560 portable ventilator, the public engineering files are complex, incomplete, and sometimes outdated.

With the United States being the global leader in new––and cumulative––COVID-19 cases, American legislators are taking notes from design guidelines in the European Union which approach right to repair from an energy efficiency perspective. While the legislative focus in the states is combatting the resource strain from the pandemic, legislators should aspire to mirror the zealous advocacy for repair rights seen in the EU.

The first brick was laid in August 2020, when Senator Ron Wyden (D-Ore.) and Representative Yvette D. Clarke (D-N.Y.) introduced H.R. 7965, The Critical Medical Infrastructure Right-to-Repair Act of 2020 (the Act), which would ease technician’s access to the information necessary for maintaining and repairing critical medical infrastructure. This initiative comes after a letter signed by over 300 technicians addressed to California legislators called for manufacturers to stop withholding necessary repair tools. The Act has an intended duration contingent on the life of the COVID-19 medical crisis, but the mechanism for accessible repair of medical equipment should extend beyond the point of crisis.

Leave a Comment

Filed under Uncategorized