Category: Blog

            Between one to three million cases of domestic violence are reported nationally every year; however, there are an estimated ten million victims when including unreported cases. Historically, domestic violence was considered a familial matter that should be dealt with in the home, not in the courtroom. Slowly but steadily, the Battered Women’s Movement created the beginning of domestic and family violence concerns in the legal sphere. The movement, with a slogan of “we will not be beaten,” sought to raise public awareness of domestic violence and advocate for better policy. The movement focused on battered women’s syndrome as a way to psychologically describe the effect of long-term trauma in abusive relationships, and was used as an expanded self-defense argument in court. Continuing into the 1960’s, the first cases of domestic violence were transferred from criminal courts into family courts in New York. With the prominence of domestic violence as a national concern, the advocates began to debate the best approach to minimize the violence.

            The Victim of Crime Act (VOCA), passed by Congress in 1984 and amended in 1988, was established to provide funding to states for victim assistance and compensation programs for victims of violent crimes. However, it was not until 1994 that the first federal law was created directed towards domestic violence. The Violence Against Women’s Act (VAWA), which recognized domestic violence and sexual assault as a national crime, highlighted that the creation of federal law can help relieve state and local criminal justice systems that are overburdened with family violence matters through much needed funding and large scale resources.

In further effort to decrease violence, on March 20, 2023, the Department of Health and Human Services (DHHS) announced a new office under the Administration for Children and Families (ACF): the Office of Family Violence Prevention and Services (OFVPS). The office was created with the goal of prioritizing domestic violence prevention and educating the intersections of preventative work throughout the federal government. OFVPS has 3 main goals: to develop an AFC-wide action plan regarding domestic violence within social service programs, coordinate and collaborate efforts with agency partners, and prioritize continued implementation of appropriations.

Most notably under this department, Representative Lucy McBath reintroduced the Family Violence Prevention and Services Improvement Act (FVPSA), which will reauthorize and expand funding for survivor support programs and preventative family violence programs.

FVPSA was originally introduced in 1984 and was again reauthorized on April 13, 2023. The FVPSA is now the primary stream of funding for emergency shelters and victim assistance programs for domestic violence survivors and their children. Compared to VOCA and VAWA, it is the only federal source that is specifically dedicated to funding domestic violence services. The domestic violence programs provide survivors with vital resources such as shelters, safety planning, crisis counseling, legal advocacy routes, and other support services to leave their abusive partners. 

Funding under VAWA, VOCA, and FVPSA has shown to improve nationwide responses to domestic violence and other forms of sexual violence at both the federal, state, and local level.

FVPSA alone currently provides to over 1.3 million victims and their families every year. Through this Act, funding for domestic violence has been federally increased to roughly two hundred and fifty million dollars. Culturally specific programs will be expanded for larger access, and in combination with the VAWA Reauthorization Act of 2022, Indian Tribes have a stronger capacity to exercise their sovereignty over cases of domestic violence within tribal land. However, despite these resources, domestic violence remains rampant.

Domestic violence is a silent epidemic in America, and since the COVID-19 pandemic, demand for domestic violence services has only increased. Unfortunately, domestic and sexual violence services face continual budget deficiencies with the continual increasing demand. Federal funding should be increased and allocated towards preventative measures to decrease victimization, in addition to the continual focus on remedial support for victims and their families. As of May 25, 2023, the Biden Administration has released a national strategy plan to end gender-based violence. This plan includes elevating the office FVPS, establishing new FVPSA grants, and allocating increased funds to Department of Justice VAWA programs. If continued into the next administration, federal funding shows a positive step towards combatting domestic violence.

            The coronavirus pandemic has had far-reaching effects in various sectors of health law, including medical malpractice. Within the malpractice sector, there have been changes to how claims are litigated because ofemergency statutes changing liability, and there will likely be an increase in claims due to an increase in hospital-acquired infections. As a result, hospital systems are being forced to respond with higher-than-expected costs of litigating these malpractice claims and are passing on these cost issues to future patients through decreased available capital.

            The U.S. has mirrored an international model limiting liability in response to the pandemic. Italy, after seeing its first wave of COVID-19 cases, limited the legal responsibility of hospital professionals to gross negligence. An Italian study of medical malpractice in a COVID-19 setting identified two critical points that were subsequently addressed with U.S. liability statutes: the pandemic had a heavy burden on healthcare resources, and because of limited understanding, treatment and preventative measures were limited.

Statutes enacted during the pandemic limited the ability of some patients to seek out medical malpractice claims surrounding COVID-19 care and hospitalizations. The federal government responded with §3215 of The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which immunized volunteer healthcare workers from liability when providing COVID-19 services during the emergency response.

States also responded with liability limitations protecting healthcare workers which are now starting to see claims being brought. New York, for example, enacted the Emergency Disaster Treatment Protection Act (EDTPA) which immunized hospitals from liability for COVID-19 related services with the exceptions of “willful or intentional criminal misconduct, gross negligence, recklessness, or intentional infliction of harm.” The act has since been repealed, but it was enacted at the time of a patient’s 2020 death. In the subsequent lawsuit, the healthcare workers were found to not be liable since they were not grossly negligent. Similar cases are likely to follow, but the costs of litigating these claims will remain for both parties.

            Despite liability limits, malpractice claims may continue to rise in the ongoing fight against COVID-19. As hospitals faced workforce shortages and health worker burnout and trauma, many had to restructure their floors and create new COVID units with ever-limited staff. As a result, the number of hospital-associated infections (HAIs) understandably increased. During 2020 and 2021, following the initial start of the U.S. based pandemic response, central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia all increased over 2019 data. From 2019 to the third quarter of 2021, ventilator-associated events increased by 60%. These numbers suggest even more claims will arise out of the pandemic as patients recover and seek out remedies for their unnecessarily long and traumatic hospital stays resulting from their HAIs.

            These changes are resulting in higher than anticipated litigation costs to hospitals. This is impacting their ability to budget on top of a decrease in operating margins from the pandemic. Together, these limits on projected income and increased output for litigation costs are negatively impacting patients further; break-even margins force hospitals to restrict spending and limit investments in patient futures. As the number of HAIs has increased, so have claims, and therefore the cost of litigating has increased. This cost is being passed off to patients in the form of decreased future health expenditures and may create even more malpractice claims in the future as hospitals struggle to keep up.

By Emilee Daniel

Extreme heat is leading to a health crisis in the United States. According to the Centers for Disease Control, 658 people die due to extreme heat every year on average. The number of people impacted by heat-related illnesses, like heat exhaustion and stroke, is even higher. American healthcare costs for heat-related and heat-adjacent illnesses are estimated to hit $1 billion per summer. Further, heat-related hospitalization costs are higher for Medicaid and Medicare recipients.

            States are getting creative to combat heat-related illnesses and hospitalization costs, especially for Medicaid recipients. For example, Oregon will begin offering free climate devices, like air conditioners and refrigeration units, to qualifying individuals starting January 1^st, 2024. Five states and American Samoa offer cooling assistance through the Low Income Home Energy Assistance Program, but Oregon’s program has a different statutory basis.

            Oregon’s program will be administered through the Oregon Health Plan (OHP), the state’s Medicaid and Children’s Health Insurance Program (CHIP) embodiments. Medicaid was established in 1965 as an amendment to the Social Security Act. Section 1115 of the Social Security Act allows states to propose “any experimental, pilot, or demonstration project … to promote the objectives” of Medicaid, so long as the project “would result in an impact on eligibility, enrollment, benefits, cost-sharing, or financing” of the state’s Medicaid program.

            On January 7^th, 2021, CMS released  guidance for State Health Officials exemplifying the breadth of possible programs under Section 1115. The guidance listed categories of support that may address social determinants of health such as: housing-relating services and supports, non-medical transportation, home-delivered meals, educational and employment services, and community integration initiatives. In accordance with Section 1115, these program’s goals are to “lower health care costs, improve health outcomes, and increase the cost-effectiveness of health care services and interventions for Medicaid and CHIP beneficiaries.

Guidance published by CMS on January 4^th, 2023 elaborated on the power of Section 1115. This guidance detailed how to propose services that would stand in lieu of a traditional healthcare facility, like a hospital. The goals of these programs are to “offset potential future acute and institutional care and improve quality, health outcomes, and enrollee experience.”

As of November 2^nd, 2022, Oregon was one of twenty-two states that had submitted proposals for or been approved to implement a program under Section 1115to address social determinants of health. One program in North Carolina delivers fresh produce to Medicaid recipients in hopes to fend off diabetes and other nutrition-related diseases. In West Virginia, a program expands access to substance use disorder treatments, housing while in recovery, and peer support services for Medicaid recipients. Arizona used Section 1115 to integrate health plans, manage long-term health plans, and expand dental coverage to Medicaid recipients, as well as those in its Urban Indian health program.

Although approaches to Section 1115 and Medicaid eligibility differed greatly between the Trump and Biden Administrations, states like Oregon continue to propose, implement, and oversee inventive projects to bolster the Medicaid system. Hopefully, Section 1115 will give rise to data-backed programs that Congress and CMS can implement on a national level.

By Paulina Andrews

Few cybersecurity attacks on hospitals involve reading a newspaper through an IV bag because hackers removed physician access to the CT machines, but ransomware and cyber-attacks can have terrifying consequences. In a January 2018 ransomware attack on Indiana hospitals, one hospital paid the hackers in Bitcoin to regain access to its systems. Days later, an attack on Allscripts, an electronic health record company, resulted in over 64,000 hospitals, ambulatory facilities, and other healthcare organizations losing access to patient records and the ability to prescribe medications. Attacks on internet medical devices, such as pacemakers and insulin pumps, and on hospital monitoring and administering systems of this magnitude are rare, but smaller-scale attacks are more common. These devices are connected to the hospital’s internet, causing one infected device to carry the virus to the entire hospital, or worse, the entire network.

Medical devices tend to have weak security, which hackers take advantage of to access hospital systems. Hackers then steal the Social Security numbers of patients or lock physicians out of medical records to ransom system access, making physicians unable to prescribe medicine or monitor  patients’ conditions. On September 27, 2023, the Food and Drug Administration (“FDA”) issued guidance stating that these “[c]ybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally.” In a research report cited by the Federal Bureau of Investigation (“FBI”), the FBI reiterated that “[fifty-three percent] of connected medical devices and other internet of things [“IoT”] devices in hospitals had known critical vulnerabilities.”

In December 2022, President Joe Biden signed the U.S. Omnibus Bill (“Bill”), also known as the Consolidated Appropriations Act of 2023, in part amending the Federal Food, Drug, and Cosmetic (“FD&C”) Act. The Bill added Section 524B to the FD&C Act to “Ensure Cybersecurity of Devices” by providing standards for medical device companies and manufacturers. The FDA was previously criticized by the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) for failing to address cybersecurity risks that medical devices pose. With the growth of technology and the internet outdating the FDA’s 2005 guidance on Cybersecurity for Networked Medical Devices, the FDA will now be required to update its Cybersecurity in Medical Devices industry guidance every two years. The goal of this guidance is to modernize healthcare and prevent cybersecurity incidents.

The FDA, responsible for approving medical devices in the United States, now has explicit statutory authority to regulate the cybersecurity of medical devices. Medical device companies will have to meet, among other requirements, certain safety certifications and assess risk management. The guidance recommends these companies follow a Secure Product Development Framework (“SPDF”): “a set of processes that help identify and reduce the number and severity of vulnerabilities” in pre-market medical devices and “encompass[e] all aspects of a product’s lifecycle, including design, development, release, support, and decommission.” Medical device companies and manufacturers will be required to perform frequent post-market software updates as needed to remain secure. Along with cybersecurity guidance documents, the FDA has released videos to help healthcare facilities develop emergency preparedness plans for cybersecurity attacks or other incidents.

The pre-market obligations the FDA is imposing on medical device companies and manufacturers will require these manufacturers to change their pre- and post-market operations to obtain approval and/or remain compliant. These manufacturers will be required to alter both their products and their quality management systems to create and maintain secure medical devices. Additional security updates may slow down a device’s operating ability or cause devices to quickly become obsolete, possibly resulting in patients being unable to use devices effectively or afford a frequent turnover of devices. While technology is evolving and hackers are continuously developing more advanced tactics, and while too much security can harm a system more than help it, the two-year cycle on guidance updates will ensure that FDA guidance and medical security measures are modern.

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.