Category: Blog

By Giulia Pastore

On September 1, 2023, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to establish minimum staffing requirements for nursing homes as part of President Biden’s Nursing Home Reform initiative. The Biden-Harris Administration announced its commitment to improving the safety, quality of care, and accountability in nursing homes in February 2022, after the Covid-19 pandemic took the lives of over 200,000 long term care (LTC) facility residents.

The Covid-19 pandemic exacerbated and exposed the consequences of inadequate staffing levels in LTC facilities and directed attention to the lack of oversight and the longstanding safety concerns that these facilities face.

Currently, federal regulations for nursing homes only require that staffing be “sufficient,” but failure to define “sufficient” has allowed for fatal inconsistencies in the level of care provided by LTC facilities across the country. Federal regulations require that a registered nurse (RN) be on site eight hours a day and that licensed nurse staff is available 24 hours a day, but these standards do not specify the type of staff that must be employed for each resident, how much time should be spent on patient care, nor do they provide a staff to resident ratio. Furthermore, lack of oversight and regulation allows for even the minimum staffing standards to go unmet.

Thousands of nursing homes go uninspected as a result of severely understaffed and underfunded survey agencies. There is doubt whether the proposed CMS staffing mandate could result in meaningful change for nursing home residents unless there is also an increase of surveyors to inspect nursing homes and respond to complaints of neglect and abuse.

Studies have shown that insufficient staffing in long term care facilities can lead to poor patient care and an increased risk of injury. If immobile residents are not properly repositioned they can develop pressure sores, which if left untreated can lead to serious infection and even death. Inadequate staffing in LTC facilities often results in residents being neglected for hours in unsanitary situations or can lead to patients falling while attempting to assist themselves.

Under the proposed rule, LTC facilities would be required to provide each resident with a minimum of three hours of direct care daily: 0.55 hours of this allotment would come from a RN and 2.45 hours of daily care would come from nurse aides. In addition, CMS would require a RN to be on site 24/7. These provisions would require LTC facilities across the country to hire additional nursing staff to avoid proposed penalties.

Some advocates are concerned that these new standards are not strict enough, but there is more widespread concern that nursing homes will be unable to comply with these minimum staffing requirements— calling the unfunded mandate “unrealistic,” given the labor shortage and high cost of care.

The Nursing Home Staffing Study, commissioned by CMS, estimates that LTC facilities would have to pay billions more in staffing costs to implement even the lowest proposed staffing minimums. The Staffing Study acknowledges the difficulties associated with implementing the proposed staffing requirements, such as nursing workforce shortages. Nevertheless, the data produced by the study indicated that additional staffing would increase safety and quality care for residents.

Currently, over 80% of nursing homes would need to hire additional nursing staff to meet the proposed requirements. However, for some nursing homes, these staffing minimums could be an impassible barrier. LTC facilities already report having difficulty hiring care workers, frequently citing a lack of funding and competition from higher paying agency positions as a major issue.

As part of the proposed rule, CMS included a “hardship exemption,” which may exempt LTC facilities that are unable to meet proposed minimum staffing requirements. To qualify, the LTC facility must demonstrate: low workforce availability, or that the facility is 20 miles away from the nearest LTC facility; good faith efforts to hire staff; and a financial commitment to staffing. This exemption could be extended on a yearly basis.  Comments on the proposed rule are due by November 6, 2023.

By India Baker

In the United States, people of color experience higher rates of health disparities compared to white individuals, much of which can be traced to historical redlining practices.  Redlining began in the 1930s when the Home Owners’ Loan Corporation (HOLC) aimed to increase suburban home ownership among white individuals.  To accomplish this goal, the HOLC drew maps that illustrated which neighborhoods they believed were safe to ensure mortgage loans.  If the HOLC believed that a neighborhood was safe for investment, they colored it green (best) or blue (still desirable).  If the HOLC believed that a neighborhood was risky for investment, they colored it yellow (declining) or red (hazardous).  In general, communities of color were colored red and white communities were colored green.

Due to redlining policies, people of color were prevented from accessing home loans, which they could have used to buy homes in the suburbs.  Consequently, communities of color were unable to acquire the same level of home equity as white individuals, which led to a substantial racial wealth gap in the United States.

Since the institution of redlining maps, elected officials have made some efforts to address and prohibit residential segregation.  In 1968, elected officials passed the Fair Housing Act, which prohibited discriminatory lending practices.  Although redlining practices are now illegal, the effects of discriminatory lending practices are still present as redlined communities remain hyper-segregated.

Elected officials should continue to address the effects of historic redlining practices to not only close the racial wealth gap, but also improve health outcomes.  Specifically, studies have established a link between redlining practices and poor health outcomes, as redlined communities experience, among other conditions, an “increased risk of diabetes, hypertension, and early mortality due to heart disease.” 

One reason redlined communities experience increased health disparities is because they are more likely to be food deserts.  Food deserts are communities that lack access to healthy food.  Specifically, “a census tract is considered a food desert if it meets a certain threshold of poverty, and if at least 500 people or one-third of the population reside more than a mile from a large grocery store.”  Communities of color tend to be food deserts due to “supermarket redlining.”  In general, chain supermarkets prefer to be located in the suburbs rather than in inner-cities because they want to avoid “perceived ‘urban obstacles.’”  In other words, chain supermarkets believe that it is more profitable to be in the suburbs due to increased demand and lower operating costs.

Recent efforts have been made to improve healthy food access in redlined communities.  For example, the United States Department of Agriculture (USDA) launched the Healthy Food Financing Initiative (HFFI) to help increase access to healthy food.  As of August 2023, the HFFI includes public-private partnerships.  Under President Biden’s American Rescue Plan, the HFFI Partnerships Program will be able to award $30 million in grants.  Once awarded, grant recipients can use the funding to facilitate “capacity building activities,” such as performing research, as well as “credit enhancement activities.”  While these initiatives are a start, elected officials should continue to make strides to expand healthy food access for underserved communities.  All individuals deserve access to healthy food, not just individuals who live in the suburbs.

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.