Category: Blog

By Tyanna Robinson

In the ongoing conversation about mental health and wellness, the Peace Corps has become a focal point in addressing the issue of stigma. The Peace Corps is an independent government agency aiming to provide sustainable solutions to the world’s humanitarian crises. It deploys volunteers to address challenges relating to agriculture, economic development, health, education, and the environment. To become a Peace Corps volunteer, applicants are required to undergo an extensive recruitment process in which they undergo medical screening. However, the health screening policy has come under fire as many have accused the program of discrimination against individuals with histories of mental health conditions.

The Peace Corps is the subject of an ongoing class-action lawsuit where the plaintiff alleges she was denied medical clearance based on a history of mental health challenges. In Doe v. Spahn, the plaintiff claims the Peace Corps offered her a job in February 2020 as a volunteer, but after completing a “Health History Form,” the organization denied her medical clearance. While the Peace Corps medical clearance policy holds that current and/or past engagement in mental health counseling alone is not a reason for medical non-clearance, the suit also includes nine other individuals whose invitations were also rescinded for mental health reasons revealing a problematic pattern.

The Peace Corps remains unwavering in its support and application of its current medical and health policy. They note that statutory responsibility falls upon the agency to provide any necessary medical care for volunteers during service. If an individual were to face a mental health crisis overseas, the agency may not be able to readily address the situation with the same care and resources that are more easily accessible in the United States. However, those challenging the policy express that rejection of this type has been demoralizing for applicants who consider why reasonable accommodations have not been implemented to make room for the growing number of individuals with a history of treatment or counseling. They also allege that these decisions were not made based on current medical knowledge, questioning whether the Peace Corps’ information used for decision-making is accurate and up-to-date.

Mental health advocates express growing concern about the healthcare system’s ability, at the legal and policy levels, to keep up with increasing numbers of individuals grappling with mental health challenges and those seeking treatment. While the Peace Corps encourages full disclosure of an applicant’s medical history to consider their health needs, the stigma and misinformation surrounding mental health make these issues harder to discuss despite the increase in mental health conditions among adults. Potential rejection from opportunities, relationships, jobs, etc. can make people fearful of being honest about their histories with mental health challenges. Therefore, the Peace Corps may see a decrease in support and applications as these health screening policies continue to alienate potentially qualified and motivated volunteers.

By Veronica Jean Walsh

The COVID-19 pandemic (pandemic) urged healthcare providers to rapidly adapt to the changing healthcare landscape, especially while Americans were encouraged to stay home to stop the spread of COVID-19. Accordingly, telehealth medicine, delivering and facilitating health services via telecommunications and digital communication technologies, became a safer and more accessible option to patients seeking healthcare.   

Before the pandemic, telehealth medicine was relatively uncommon. Providers were inexperienced with telehealth services and the technologies they required; telehealth was also  discouraged under the 2008 Ryan Haight Act, which prevented providers from prescribing controlled substances to patients without an in-person visit. The Ryan Haight Act sought to deter over-prescription of controlled substances to combat the ever-growing opioid epidemic; however, following the pandemic’s inception, the Drug Enforcement Agency (‘DEA’) saw the detrimental effects  the pandemic had on individuals requiring controlled substance prescriptions. Thus, the DEA waived the in-person visit requirement associated with the Ryan Haight Act for the public health emergency, allowing individuals requiring controlled substance prescriptions to obtain prescriptions without meeting their provider in-person.  

Nearly three years after the in-person waiver, the DEA seeks to create a permanent ruling to address telehealth medicine and controlled substance prescribing. In March 2023, the DEA proposed prohibiting providers from prescribing Schedule II and narcotic controlled substances. Providers are also limited from prescribing through telehealth and no in-person encounter Schedule II through V non-narcotic controlled substances, including buprenorphine, for more than 30 days. During the 30-day period, the patient must obtain an in-person medical examination unless referred by a provider who conducted an in-person medical evaluation.  

Following the proposed rule’s release, the DEA received many comments. Advocates of the DEA rule claim that the regulations seek to prevent the growth of the opioid epidemic. Proponents of the DEA proposed rule urge that while COVID-19 concerns have lessened, the flexibilities granted to controlled substance prescribing should be drawn back to prevent the opioid epidemic from spiraling.  

Critics of the proposed rule, however, are concerned with placing unnecessary barriers to care for vulnerable populations, since, prescribing buprenorphine, a controlled substance used to treat substance use disorder, would now require in-person evaluation. The barriers placed on buprenorphine, a medication used among vulnerable patients, are arguably counterintuitive to the DEA’s desired goal of fighting the opioid epidemic. This concern is especially prominent, as lack of access to care has exacerbated the effects of the opioid epidemic.  

Given the public outcry against the DEA’s proposed rule, the DEA decided to extend the Ryan Haight Act waivers through November 2024 while trying to find an acceptable solution. Earlier this month, the DEA held a listening session to receive additional input on whether to permit telemedicine prescribing of controlled substances without in-person evaluation. The in-person evaluation waiver for controlled substance prescribing remains in place; however, the DEA will be forced to issue a more permanent option as the extension proceeds to run. 

The False Claims Act (“FCA”), which is mainly used to litigate fraudulent Medicare claims, is being challenged in the Supreme Court. In U.S. ex. Rel. Polansky v. Executive Health Resources, Inc., Polansky argues that in granting the Department of Justice (“DOJ”) the ability to move to dismiss the realtor’s FCA complaint, the FCA deprives realtors of their status and rights. Oral arguments commenced in January 2023, and a decision is expected this Summer regarding the future of the FCA.

The FCA was enacted in 1863 during President Lincoln’s tenure. The FCA allows individuals (“whistleblowers”) to pursue litigation against those the whistleblower believes have fraudulently billed the federal government. In 2022, 90% of all FCA settlements and judgments were related to healthcare fraud. Healthcare fraud may be billing for medical services not rendered, misrepresentation of covered medical procedures as non-covered medical procedures, altering patient’s diagnoses to receive a higher payment, billing for services not performed, accepting kickbacks for referrals, or unbundling procedures and billing a single procedure at every stage of the interaction to receive a higher payment.

The consequence of Medicare fraud is higher insurance premiums for Medicare Advantage policyholders. To make up for Medicare’s payments to fraudulent claims, Medicare Advantage plans adjust premium prices for the coming year to make up for fraudulent claims . Thus, policyholders pay more monthly to mitigate the Medicare Advantage plans’ payments toward fraudulent claims.

The FCA provides a pathway for whistleblowers who have experienced Medicare fraud. The DOJ has intervened in 261 cases this past year, the highest amount since 1993. However, in 2022, for the first time in history, the recovered amount for cases where the DOJ has not intervened surpassed the amount recovered in DOJ-intervened cases. Additionally, in that same year, about half of all awards for claims under the FCA were from cases where the DOJ declined to intervene.

In Polansky, the DOJ declined to intervene after investigating the claim for two years but maintained the right to move to dismiss. About seven years after the case’s inception, the DOJ then moved to dismiss the lawsuit, citing that the cost of litigating the claim did not outweigh the benefit of an award. Polansky is claiming the DOJ’s dismissal of the claim, stopping litigation in its tracks, is a deprivation of the whistleblower’s rights. Currently, the DOJ has broad discretion in dismissing claims under the FCA. If the Supreme Court finds Polansky’s arguments convincing, then the ability of whistleblowers to sue medical care providers for fraudulent billing would increase, as the DOJ would be barred from dismissing claims freely. However, the DOJ states that its broad discretion, which allows the DOJ to dismiss claims where the cost of litigating will not benefit the government or whistleblower, should be maintained.

Today, committing Medicare fraud is less of a challenge than one would assume. A fake company was set up in Florida as a Medicare fraud front. All that was required was setting up a P.O. box for the fake company. The fake company billed Medicare over $500,000 for patients that did not exist. On average, taxpayers lose more than $100 billion annually to Medicare and Medicaid fraud.

Furthermore, Medicare fraud creates expensive repercussions for policyholders. Although the FCA creates an avenue for individuals to sue billers who have engaged in fraudulent practices, if the Supreme Court agrees with the government, the decision may result in a chilling effect among policyholders,  reducing FCA litigation and compounding the damaging impacts for individuals. 

There may be no stranger with whom the average person shares more private details of their life with than their doctor. The primary healthcare mechanism to protect patient privacy in healthcare, the Health Insurance Portability and Accountability Act (“HIPAA”) was passed in 1996, but was, as its title suggests, heavily focused on insurance-related concerns, and left gaping holes in much of the healthcare data privacy space. Under HIPAA, personal health information can be sold by healthcare organizations, used for marketing purposes, and shared with research organizations, as long as the data is de-identified, or the patient authorizes such uses.

While many patients are incredibly skeptical of their health information being shared, even with identifying details stripped from the data, there are incredibly important reasons to embrace and support a robust data-sharing model: to provide drug manufacturers with patient data about side effects and adverse reactions, to allow researchers to uncover and analyze systemic trends and anomalies, and to allow for the most comprehensive and holistic data-driven modeling. Much of patient skepticism may be due to the unfamiliarity with how their data is used – in a 2022 survey, only 20% of patients indicated an understanding of who has access to their healthcare information.

            Two recent developments have further exacerbated the problems around patient skepticism – the post-Dobbs criminalization of abortion, and the furor around TikTok. Although much of the legislation criminalizing abortion targets health care providers and clinical staff, the mere fact that, in some states, abortions are now a felony with potential jail time will likely cause patient unrest and fear. Even though Justice Kavanaugh’s concurrence in the Dobbs decision suggested that pregnant persons will still have the right to travel out of state to obtain abortion services, there is little clarity or guidance on what data law enforcement may be able to collect, even if the abortion occurred out-of-state. If patient data privacy concerns related to abortion procedures are not addressed, the skepticism and fear may seep into other types of healthcare and further impede the robust sharing of healthcare information.

            To that end, the discussions around banning TikTok demonstrate the general concern that user data, including personal health information, may be in the hands of the Chinese Communist Party, which would have far-reaching implications. Like the concerns surrounding abortion, skepticism and fear about what data from social media is being shared, and with whom, decreases consumer/patient willingness to share personal information in ways that may be beneficial to them.

There is already an undeniable overlap between healthcare and social media. One of the risks of conflating the two is that third-party data sharing in the healthcare space may be inadvertently equated with sharing data with social media platforms. For the purposes of sharing data with third parties, even when de-identified, should AstraZeneca, collecting patient information to improve a vaccine, be considered equivalent to TikTok collecting information for advertising purposes?

Much of the current proposed legislation is aimed at increasing data privacy and security. The American Data Privacy and Protection Act (ADPPA), proposed last year, would create additional protections for sensitive data, though data covered under HIPAA is outside its scope. Last month, Democratic senators introduced the Upholding Protections for Health and Online Location Data Privacy Act (UPHOLD), which would give consumers more control over their health data and restrict companies’ ability to collect and/or use data without patient consent. On the other hand, the Health Information Technology for Economic and Clinical Health Act (HITECH), enacted in 2009, was intended to address privacy and data security concerns by increasing the civil and criminal penalties associated with HIPAA violations, with the goal of promoting the “adoption and meaningful use of health information technology.”

Despite the continued emphasis on increasing and broadening data privacy rights and consumers’ ability to control how their data is disseminated, it is critical that the importance of sharing health data with relevant third parties not be minimized or vilified. Innovation in healthcare depends on pharmaceutical companies, academic researchers, and others, having access to the most current, comprehensive patient data.

Although the word telehealth is new in most of our vocabularies, the idea itself is not. As early as 1925, doctors were diagnosing patients over the radio, and in 1959 patients and physicians were using video telecommunications to connect with one another. 

Telehealth now, however, is booming. In the year between March 2019 to March 2020, Telehealth usage increased an astounding 154%. Among Medicaid beneficiaries in a select five states, telehealth usage increased 15x from the pre-pandemic usage of 2.1 million visits per year, to over 32 million visits from March 2020 to April 2021.

Although telehealth has its inherent benefits , such as allowing patients to visit doctors from the comfort of their homes, thus saving them time, money, and allowing for fewer missed hours from work, it also has its drawbacks. Disadvantages to telehealth include racial disparities , possible technical difficulties between patient and doctor, misdiagnosis, and privacy concerns.

One of the leading disparities in telehealth is the digital divide. In a study conducted by the University of Houston, head researcher, Omolola Adepoju, found that only one in four families earning $30,000 or less have a smart device capable of running telehealth communications software such as Zoom or Skype. Further, the study found that 66% of African Americans and 61% of Hispanics have high-speed internet access, compared with 79% of white households.

Further challenges were illustrated by the National Center for Biotechnology Information (NCBI), which extracted 27 studies from seven databases, and organized the barriers and challenges to telehealth into seven categories. In order of frequency (most frequent challenge to telehealth, to least frequent): technical aspects, privacy/data confidentiality and reimbursement, physical examination and diagnostics, special populations, training of healthcare providers and patients, doctor-patient relationship, and acceptability and satisfaction.

The second biggest barrier to telehealth, as reported in the NCBI’s report, was privacy/data confidentiality concerns. Patients were afraid that using a telehealth service would subject their intimate data to security breaches. These fears were not baseless. During the COVID-19 public health emergency, the Department of Health and Human Services Secretary Alex Azar issued temporary waivers that waived Medicare’s licensure requirements and allowed health providers to use mainstream video-conferencing platforms like Zoom and Google Meet. Further, smartphone apps, sometimes used in place of Zoom and Google Meet, have been found to share personal health information  with third parties.

Although federal policies allowed for health care providers to use popular third party vide conferencing platforms, there are some simple steps we can take to ensure privacy when meeting with health care providers via telehealth. When sharing sensitive health information online, it is important to remember a few precautions we can take to limit the possibility of our information being hacked. First, make sure to keep your devices up to date with antivirus software; second, avoid using public Wi-Fi when accessing telehealth services; and third, avoid accessing telehealth appointments on shared devices. Further, once in an appointment, try to ensure that you are in a private room away from others, and if impossible, let your healthcare provider know, and then you may be able to send sensitive information via text or email through their own protected portal rather than speaking aloud.

As COVID-19 cases are trending down and are presenting less of a public health emergency (which the Department of Health and Human Services plans to officially end on May 11, 2023), it is time for lawmakers and politicians to seriously think about the impacts unregulated telehealth has on the privacy of its users, especially as it relates to marginalized groups.

Ozempic is an antidiabetic medication developed by Novo Nordisk in 2012 and the United States Food and Drug Administration (FDA) first approved the medication in 2017. Used for the treatment of type 2 diabetes, Ozempic is designed to be injected once a week in the stomach, thigh, or arm. In February, Novo Nordisk warned of supply constraints this year on Ozempic. In March, after months of shortages, the FDA announced that Ozempic is back on the shelves in the United States. The demand for Ozempic was assumed to be partly driven by prescriptions for non-diabetic patients seeking to lose weight, which is outside the drug’s approved indication.

Ozempic impacts weight via two key mechanisms. First, it affects the hunger centers in the brain,specifically in the hypothalamus, reducing hunger, appetite and cravings. Second, it slows the rate of stomach emptying, which effectively prolongs fullness and satiety after meals. The net result is decreased hunger, prolonged fullness, and, ultimately, weight loss. In a clinical trial sponsored by Novo Nordisk, 1,961 adults with excess weight or obesity who did not have diabetes were given 2.4 milligrams of semaglutide, the active ingredient in Ozempic, or a placebo once a week for 68 weeks, along with lifestyle intervention. Those who took semaglutide lost 14.9 percent of their body weight compared with 2.4 percent for those who took the placebo.

In 2022, Ozempic exploded onto the scene and gained attention among celebrities and TikTok influencers who were trying to lose weight in short periods of time. Although Ozempic can help someone lose fifteen to twenty percent of their body weight, any lost weight reportedly comes right back if you do not take the drug every week. Thus, people who start a prescription typically do not stop taking it, even when they reach their goal weight.

People taking Ozempic for both FDA approved and off-label use may experience side effects. These include nausea, dehydration, fatigue, malaise, diarrhea, and constipation. In rare cases, the medication could increase the risk of pancreatitis. Because the drug has not been systematically tested in people with lower body weights it is possible that patients outside of the group the drug is intended for could experience more intense side effects. Without more research, it is unclear just how damaging those side effects could be.

In addition to these physical side effects, there are also psychological side effects. Dieting is one of the leading risks for developing an eating disorder and medications such as Ozempic could lead to more disordered eating as people try to avoid regaining weight.

Doctors say there is not enough evidence to know whether Ozempic might be beneficial or dangerous for people who fall outside of the FDA’s criteria. As tempting as the prospect of a “miracle drug” for weight loss may be, experts caution against people seeking out the medication for off-label use.