Category: Blog

In February 2020, Dominic Trumbo, a patient recruiter based out of Lexington, Kentucky was sentenced to 60 months in prison for receiving over $1 million in illegal kickback money from several home health agencies throughout the nation in exchange for information on Medicare beneficiaries. Trumbo instructed his employees to cold-call Medicare beneficiaries and offer incentives to get them to sign up for home health care. Trumbo then sold the Medicare beneficiary information to home health agencies around the country in exchange for illegal kickback payments. The evidence at trial further showed that Trumbo and his co-conspirators went to great lengths to conceal their scheme to defraud Medicare, creating sham contracts and fake invoices to cover their tracks. 

The Anti-Kickback Statute (AKS), enacted in 1972, is the criminal law that took down the Trumbo empire. The AKS prohibits the “knowing and willful payment” of so-called “remuneration” (essentially gifts; such as free rent, expensive hotels, meals, etc.) to induce and/or reward patient referrals. Criminal penalties for violating the AKS include large fines, prison time, and exclusion from participation in federal health care programs. The government need not even prove patient harm or financial loss to programs to prove a violation of AKS; taking money or gifts from medical sales companies, for example, can land physicians in serious trouble. Kickbacks can lead to overutilization, increased costs of healthcare services, and corrupt medical decision-making, steering patients away from medically valid services and/or therapies and unfair service delivery.

In December 2023, Community Health Network Inc., based out of Indianapolis, Indiana, was required to pay $345 million in a settlement to resolve allegations that it violated the False Claims Act by knowingly submitting claims to Medicare for services that were referred in violation of the Stark Law. The U.S. government alleged that the scheme began in 2008 when Community Health Network began to recruit physicians for employment for the purpose of capturing their “downstream referrals.” Over the years, Community Health Network successfully recruited hundreds of local doctors, in an array of specialties, by paying salaries significantly higher than market-rate at their own practices. 

The Physician Self-Referral Law, also commonly referred to as the Stark law, was first enacted in 1992 to limit the financial relationships that physicians may enter into, Stark further expanded in 1995 to encompass the “designated health services” (DHS) that patients receive. The DHS refers to the health facility or institution that performs services such as occupational therapies, clinical laboratory testing, radiology services, medical equipment, inpatient hospital services, outpatient prescription services, or home health services. The Stark law broadly seeks to prevent doctors from referring patients to the DHS if there is a financial relationship present between the physician and the healthcare entity, their immediate family member, and the healthcare entity. 

            On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released a final rule in hopes of modernizing and clarifying the regulations that interpret Stark law which has not been significantly updated since 1995. According to CMS, the final rule notes that “for the first time, the regulations will support the necessary evolution of the American healthcare delivery and payment system.”  Using this final rule, in 2022, CMS settled a record-breaking 104 Stark law self-disclosures, which totaled over $9.2 million, almost quadruple the 2021 settlements. 

Henry Ford Health is an integrated healthcare organization based in Michigan, and in an ongoing federal court case, Sparks v. Henry Ford Health System et al., the organization was sued for alleged disability discrimination in violation of the Patient Protection and Affordable Care Act (ACA).

The Plaintiff in this case, Kerri Sparks, is a frequent patient of one of the organization’s hospitals and requested an in-person interpreter for an upcoming pre-surgery education class since she is deaf and can only communicate through American Sign Language (ASL) and by lip reading. Due to a clerical error, the hospital’s in-person ASL interpreter was unavailable, so the hospital deployed a Video Remote Interpreter (VRI). Due to connection issues, Sparks was left without an interpreter. Sparks was given a printout of the information covered in the class and the instructor wore a clear face shield so that Sparks could lip read, but despite these efforts, Sparks was unable to understand what the instructor was saying and left the class confused about her upcoming surgery.

Despite Sparks’ request for an interpreter on the day of her surgery, the hospital failed to provide one. Although not fluent in ASL, the hospital had Sparks’ boyfriend interpret for her, leaving Sparks once again confused and unable to communicate with staff regarding her surgery.

Section 1557 of the Affordable Care Act prohibits “discrimination on the basis of race, color, national origin, sex, age or disability in a health program or activity, any part of which is receiving Federal financial assistance.” Congress implemented this provision with the understanding that discrimination in healthcare settings can contribute to disparities, especially when it results in a patient being unable to comprehend the nature and consequences of the healthcare services being provided to them. Section 1557 stipulates that healthcare providers receiving federal financial assistance, like Henry Ford Health, must “take appropriate steps to ensure that communications with individuals with disabilities are as effective as communications with others in such programs or activities.”

The U.S. District Court in the Eastern District of Michigan found there to be genuine issues as to whether the hospital provided Sparks with the auxiliary aid necessary to ensure effective communication for surgery and was unable to resolve this question on summary judgment. The parties have yet to settle and are moving towards trial.

Deaf patients like Sparks experience significant health disparities and are at an increased likelihood of experiencing inadequate communication with doctors and other medical staff. It is estimated that there are around 500,000 to one million deaf users of American Sign Language (ASL) in the United States, and many of whom have experienced interpreter-related barriers to healthcare services. Deaf patients are more likely to experience misunderstandings and a lack of communication when sign language interpreters are not provided to them because only a small percentage of deaf patients who use ASL have to opportunity to directly communicate with their healthcare providers.

The lack of ASL interpreters in healthcare settings is a persist issue and will continue to disadvantage the deaf community until such needs are met. Patient-provider trust relationships and effective communication have been shown to result in positive health outcomes in patients, but when ASL interpreters are either not provided or are insufficient, there is an increased likelihood that the relationship between deaf patients and their providers will be negatively impacted. To protect patients like Sparks and ensure that they are provided with the necessary information to make informed decisions about their health, medical schools should consider implementing a Deaf Health Pathway (DHP) seminar. During DHP seminars medical students shadow medical interpreters to learn the intricacies of interpretation. Through DHP, medical students learn basic ASL and grammar before progressing to learning how to communicate with deaf patients themselves. DHP immerses students in ASL and deaf culture so that America’s future doctors can bridge the gap in care for deaf communities across the country. Although DHP seminars are currently in the early stages of development and studies are needed to explore the long-term outcomes of such programs, DHP seminars might be a solution for the lack of ASL interpreters in the healthcare industry. 

Transgender individuals’ access to gender-affirming care is increasingly under attack. In response, various states are protecting access to gender-affirming healthcare through shield laws. While shield laws vary by state, the laws have two primary goals: (1) to protect transgender individuals, their families, and their medical providers against such attacks and (2) to protect access to gender-affirming health care. For instance, if an individual travels from a state where gender-affirming healthcare is banned and receives that care in another state, a shield law can protect the recipient and/or provider of that healthcare against civil or criminal charges from the state where healthcare is banned.

Currently, the makeup of shield laws in the United States is as follows:

• 11 states and the District of Columbia have shield laws protecting access to gender-affirming healthcare,
• 3 states have a shield executive order protecting access to gender-affirming healthcare,
• 36 states and 5 territories have no shield law or policy protecting access to gender-affirming healthcare, and
• 24 states have state bans or restricts gender-affirming healthcare for transgender youth.

In 2022, California passed SB 107, a shield law protecting families of transgender youth under 18 from being criminally prosecuted if they travel to California with their children to obtain gender-affirming healthcare. On Tuesday, March 26, 2024, Sacramento, California, the state’s capital, took that protection one step further: the Sacramento City Council unanimously approved a resolution to protect transgender individuals by declaring the City of Sacramento a sanctuary city. As the City of Sacramento is already a sanctuary city for immigrants, transgender individuals would receive the same protections as immigrants— that no city resources would be used to detain individuals seeking gender-affirming healthcare or cooperate with other jurisdictions to enforce their laws criminalizing gender-affirming healthcare.

The Sacramento City council proclaimed the City as a sanctuary city in preparation of “future legislation that may criminalize those providing or seeking gender-affirming care” as well as its values of equity and inclusion: “It is important for the City of Sacramento to be proactive in reiterating our commitment to transgender rights and equal protections for transgender [individuals] by declaring ourselves a sanctuary city and a place of safety for transgender [individuals]. This resolution would also resolve to ensure the rights of transgender individuals in Sacramento are upheld.”

Sacramento City Councilmember Katie Valenzuela celebrated Sacramento’s adoption of the resolution. Valenzuela posted on X, formerly Twitter, that “[b]y affirming [Sacramento’s] commitment to supporting [the] LGBTQ+ community and ensuring that no city resources or staff time will be used to help enforce these harmful laws in other jurisdictions, the City has taken a step beyond state law and sent a powerful signal to everyone in our community that we are a safe place for everyone.”

Adopting the resolution did not impact the City in any way; it only helped the City. The resolution did not have any financial impact, and it simply guaranteed that none of the City’s resources will be used to enforce laws to restrict access to gender-affirming health care for transgender individuals. As the resolution will better everyone’s lives and has no negative ramifications for the City, other cities and states should adopt similar resolutions deeming their cities or states as sanctuary cities.

On June 5, 1981, the Centers for Disease Control (CDC) announced the presence of a rare form of pneumonia in five previously healthy gay men in its Morbidity and Mortality Weekly Report — it wouldn’t be until 1986 that the Reagan administration mentioned “AIDS” in public. Around this time, about 16,500 people had perished from AIDS. With the brave advocacy of groups such as ACT UP and medical advances, the landscape of HIV/AIDS prevention and treatment has changed dramatically; available daily or long-term (injectable) treatments not only dramatically improve the quality of life for those with HIV but will even suppress the amount of virus to undetectable levels and thus become untransmittable.

In addition to innovative HIV treatment, we now have better tools for prevention. PrEP, or pre-exposure prophylaxis, is a medicine that dramatically reduces a person’s chances of HIV infection by about 99%. Through a daily antiviral tablet or quarterly injection, the medicine helps stop the virus from spreading throughout the body when taken correctly. While the use of PrEP has increased since its first approval, only an estimated 36% of those eligible for the prevention tool have received a prescription. Additionally, the equity in PrEP usage by race and ethnicity has decreased. In 2019, the Trump administration enacted the Ending the HIV Epidemic (EHE), a multi-pillar initiative to dramatically reduce new HIV diagnoses and improve the quality of care for those living with HIV. However, the impact of EHE and other initiatives is under threat by the evolving case of Braidwood Management Inc. v. Becerra.  

One of the critical features of the Affordable Care Act, Section 2713, mandated the complete coverage of preventative services graded “A” or “B’ by the U.S. Preventative Services Task Force in private employer health plans. In 2019, the USPSTF issued an “A” grade for PrEP (expanding it to injectable PrEP in 2023), meaning that private plans were now required to cover PrEP without cost-sharing. While litigation surrounding the contraceptive coverage requirements of the ACA is nothing new (see Burwell v. Hobby Lobby), Braidwood targets the preventative care provisions mentioned above.

The plaintiffs in Braidwood brought forth significant challenges to the ACA preventative care mandate: they claimed that, among other things, the mandate violated RFRA because it substantially burdened the religious exercise of plaintiffs who objected to supplying PrEP on religious grounds and that recommendations violated Article II’s Appointments Clause. The District Court held that the USPSTF members were not adequately appointed under the Appointments Clause and rejected Braidwood’s nondelegation arguments. Thus, this challenge preliminarily struck down the preventative services mandate. While the Fifth Circuit stayed the District Court’s decision in May 2023, appellate oral arguments continued on March 4, 2024.

If the Fifth Circuit upholds the District Court’s decisions, not only would private employer plans have the discretion to choose whether to cover preventative services, but it would erase the progress the nation has made in HIV prevention and treatment. One report estimates that if PrEP coverage amongst men who have sex with men decreases from 28% to 10%, it will result in 2,083 new HIV diagnoses within the next year. However, all may not be lost entirely if the Fifth Circuit doesn’t decide in favor of HHS: one proposition suggests transferring authority to recommend PrEP from the USPSTF to the CDC’s Advisory Committee on Immunization Practice (ACIP). Although only time will tell, the Fifth Circuit may uphold the District Court’s ruling and such threatens the progress we have made in HIV-treatment and prevention.

In 2014, one American town prioritized cost-saving measures over the health of its people. The city of Flint, MI imprudently decided to trade its current drinking water system, which piped treated water from the nearby city of Detroit, to a new, familiar source: the Flint River. Inadequate treatment of this new water source prompted a deadly health crisis for the locals. The crisis persisted as government officials consistently neglected ongoing issues, despite escalating complaints about the putrid, off-tasting water supplied to Flint homes and reports of various severe health issues. Finally, two years after Flint had changed its water source,  then-President Obama spoke up about the federal government’s commitment to the residents of Flint, claiming he “will not rest until every drop of water. . . is safe to drink and cook with.” Today, many are still dealing with the lingering effects of the disaster. Fortunately, this crisis received attention, with settlements disbursed to residents and ongoing government commitment to the city’s water supply.   

The abundant government aid received by Flint during its crisis contrasts sharply with the current public health emergency unfolding in Gaza, where our government is contributing to the massacre through foreign assistance in both military and economic capacities. Specifically, since 2000, the majority of annual U.S. aid to Israel has funded military efforts, primarily in the form of maintaining and updating its missile defense system. Critically, the Palestinian people are not unfamiliar with violations against their human rights at the hands of the Israeli government. For decades, Israel has ignored obligations imposed by international and humanitarian law through the calculated denial of health resources, obstruction to healthcare access, and militant attacks on Palestinian health infrastructure. Now, in the aftermath of the initial outbreak of violence of October 7, 2023, the occupied Palestinian territory of Gaza has been the target of more relentless violence, including unlawful bombardment of healthcare facilities and obstruction of supplies for basic needs. Specifically, Israeli authorities were eager to cut innocent Gazan civilian’s access to water, medical supplies and electricity, while also maintaining full control over food deliveries into Gaza. Now, more than 96% of the water supply is unfit for consumption. The U.N. Children’s Fund expressed “the death toll will increase exponentially if incubators start to fail, if hospitals go dark, if children continue to drink unsafe water and have no access to medicine when they get sick.” The current humanitarian crisis evidently doubles as an extreme public health crisis, as Israel weaponizes basic necessities.

As those in Gaza fight to survive, one may question the absence of public outrage and intervention we witnessed from American leaders during the Flint disaster. Although the ongoing Israel-Palestine conflict is happening outside our American borders, the U.S. plays an extremely integral role here. Israel has been the largest cumulative recipient of U.S. foreign aid since its inception, currently valued at around $300 billion in assistance. Meanwhile, while the U.S. Government preaches its commitment to ensuring clean, safe water access as a basic human right, that same government is directly funding an Israeli military operation drastically limiting Gazans’ access to water. As of February 29, 2024, at least 100 Gazan civilians were killed or injured from Israeli bombardment while waiting desperately for food aid dispersal. The U.S. is funding this.

The catastrophe in Flint was devastating and preventable— with an estimated 140,000 individuals exposed to the bacteria-ridden water and at least 12 deaths. Thankfully, President Obama declared a national state of emergency, authorizing the government to provide necessary equipment and resources to the people affected using federal funding. Meanwhile, the death toll in Gaza currently exceeds 30,000, a number that even experts claim is more than likely an undercount, with around 70,000 civilians injured since October 7. The U.S. is not only complicit here, but is actively aiding the oppressors. In examining the stark disparity between the government aid and accountability seen with Flint’s public health emergency and the public health tragedy in Gaza, it serves as a reminder of the need for equitable and compassionate global responses to crises, irrespective of geographical boundaries or political affiliations, as well as the importance of government accountability.

 For years, the Food and Drug Administration (FDA) has considered revising how it defines the term “healthy.” This April, the FDA is due to publish its updated definition of the term, which would change which foods manufacturers could legally claim are healthy. The definition has not been updated since 1994. That said, what makes this change particularly relevant for manufacturers and consumers is not the change in definition, which is “unlikely to significantly change which foods would be eligible [under] the new [definition].” Rather, it is that FDA is also due to release a new logo that manufacturers could put on food to denote that their product is healthy – basically a healthy stamp, similar to the USDA Organic insignia. (Draft versions of FDA’s “Healthy” symbol can be seen here.).

The FDA has the authority under the Food, Drug and Cosmetic Act (FD&C Act) to promulgate regulations over the types of claims that can be made on food packaging. This includes the power to define terms, such as “healthy.” Several alternatives exist for food manufacturers who cannot meet FDA’s definition of “healthy”, however. FDA very loosely regulates several terms which manufacturers use to convey a sense of health to consumers, such as “natural”. No such logos exist for those terms, though, potentially incentivizing food manufacturers whose products are on the fringe of FDA-defined healthiness to adjust their products’ ingredients.

That said, why put resources into developing an official “healthy” logo? Although it may not be likely to change what every shopper puts in their cart, the initiative is motivated by research suggesting that front-of-pack (FOP) labels, particularly those with an endorsement from some institutional authority (like FDA or USDA), make it easier for consumers to evaluate what they are purchasing. Obviously, part of the reason for this is the time crunch – it is easier to recognize a logo than it is to search the packaging or research a product. However, the location of information on packaging is important as well, as the FDA is also considering FOP nutrition facts, since some consumers are unlikely to look at the back of food packaging. These mini-labels would highlight added sugars, saturated fat and sodium – things consumers might want to see.

What does it mean for a food to be “healthy,” though? When FDA was taking comments over their new proposed rules, many comments philosophically questioned how FDA planned to draw a single line between healthy and unhealthy nutritional contents. While the proposed update to the definition bases itself on the Dietary Guidelines for Americans, 2020-2025 and mainly creates limits based on the percentage of Daily Value for added sugars, saturated fat and sodium, there are reasonable objections to the existence of the definition. If some food product manufacturers are going to be winners under the new “healthy” logo scheme, then other manufacturers that sell food products that could reasonably be a part of a healthy diet may unfairly take a hit. At the same time, a more detailed system of labeling, such as a health rating system or logos identifying specific nutrients, would potentially undermine the simplicity of FOP logos.