Category: Blog

Expansion of PA Newborn Safe Haven Law Requires Urgent Care Centers to Reassess Mandatory Reporting Procedures

Pennsylvania recently amended its Safe Haven laws to allow parents to surrender their newborns at urgent care centers without criminal liability. Previously, under Pennsylvania law, parents could only surrender their infants at hospitals, emergency medical services providers, and police stations without liability. However, in a recent amendment, Pennsylvania’s legislators expanded this law to include urgent care centers. Now, urgent care centers must accommodate the law through policies, training, and updates to their premises. 

The Newborn Protection Act allows parents of infants 28 days old or younger to leave the infant at these ‘safe havens’ without criminal liability, so long as the newborn is not a victim of child abuse or neglect. If a child is a victim of child abuse and being surrendered, the parents may face criminal liabilities.

Healthcare providers are mandatory reporters of child abuse, under Pennsylvania law. As a baseline, healthcare providers always must report any suspected child abuse, even if a newborn is not being surrendered. Accordingly, healthcare providers, ideally, should already be training employees to know the signs of suspected abuse and have adequate reporting procedures in place. When a provider suspects abuse, they are responsible for filing a report of the suspected abuse with law enforcement. Given that urgent care centers are healthcare providers, these facilities should already have reporting procedures and training in place for suspected abuse

Yet, because urgent care centers do not offer as robust healthcare services as hospitals, the Newborn Protection Act will require urgent care centers to transport the surrendered newborn to a hospital and place the newborn in the care of another healthcare provider within that hospital. This is an additional step that hospitals do not need to undertake, as they already have the resources to assume custody of a surrendered newborn unlike an urgent care center, which is designed to only provide temporary and acute services. 

Like hospitals, police stations, and emergency medical services providers, urgent care centers must now adequately train personnel to properly inquire into possible child abuse. Urgent care centers are now required to post signage, stating the hours in which they will accept newborns. The urgent care centers will be required to provide an incubator as well, for parents to anonymously surrender their children. Incubators lock from the inside so that third parties cannot access the surrendered newborn.

Ultimately, the Newborn Protection Act seeks to provide a safe way for parents to surrender children. However, urgent care centers will need to ensure they adapt their training and procedures to comply with the expansions of the Act as soon as possible, to ensure that they are not turning a blind eye to suspected child abuse or neglect.

Preemption or Exception? The Pandemic Era Informed Consent Debate

In August 2024, the Vermont Supreme Court decided that a family could not sue a school district, superintendent, or school nurse after their child was accidentally given a COVID-19 vaccine without parental consent. The unauthorized vaccination occurred in 2021 in the Windham Southeast School District of Brattleboro, Vermont, during a vaccine clinic hosted by the Vermont Department of Health and the school district. Prior to the clinic, the student’s father expressed to an assistant principal that the plaintiffs did not consent to have L.P. vaccinated, and on the day of the clinic, the child “verbally protested,” saying, “Dad said no.” Nonetheless, the clinic workers administer one dose of the Pfizer-BioNTech COVID-19 vaccine. Based on these events, L.P.’s family filed an eight-count complaint in the civil division alleging negligence and battery. The defendants argued that they were immune from state-law claims under the PREP Act. 

The PREP Act, passed by Congress in 2005, authorizes the Secretary of the Department of Health and Human Services to specify the distribution or use of a “covered countermeasure”. During a public health emergency, “covered persons” are immune from all claims causally related to the administration of a covered countermeasure, and vaccines fall into that class. The Vermont Supreme Court decided that the defendants were “covered persons” under the PREP Act, so while the incident exhibited a lack of parental consent, those administering the vaccines were afforded legal protections. Ultimately, the case was dismissed.

In a similar case, the North Carolina Supreme Court concluded that the broad scope of immunity provided by the PREP Act applied to clinic workers at Northwest Guilford High School. In August 2021, Brett Happel drove his fourteen-year-old stepson, Tanner Happel, to a testing site at Northwest Guilford High School after receiving a notification of possible exposure. The Happels also received a letter stating that unless parents allowed their children to be tested, student-athletes could not return to practice until cleared by a public health professional. Tanner Happel was seated in the testing facility when a clinic worker tried unsuccessfully to contact Happel’s mother and obtain consent to administer a COVID-19 vaccine to him. After failing to make contact, a worker was instructed to “give it to him anyway.” Despite Happel stating that he did not want the procedure, a clinic worker administered a Pfizer COVID-19 vaccine. 

As medical care becomes increasingly complex, practical dimensions of informed consent fall under heightened scrutiny. Requirements for informed consent may change after Congressional regulations pass and vary under different jurisdictions. Under the legal doctrine of informed consent, patients have the right to make informed and voluntary treatment decisions. This ensures that the patient is fully informed about a procedure’s nature, risks, and alternative treatments. A patient can refuse or withdraw consent at any time during treatment, but informed consent promotes trust in the patient-provider relationship.

Some online claims falsely suggest that the Vermont ruling permits vaccinations without parental consent, which is not true. However, the Vermont Supreme Court case has sparked debates on government immunity and individual rights in both emergency and public healthcare policies. The Vermont case determined civil liability in the wake of a global health crisis. Contemporaneously, the case also raises serious questions about the scope of informed consent and government authority during public health emergencies. 

The Social Cost of Wellness: New NIH Visitor Guidelines Threaten Immigrant Patients

The arrival of 2025 saw the inauguration of Donald Trump for his second term and his Administration’s takeover of the federal government. The confirmation of Robert F. Kennedy Jr. as Health Secretary means that the Trump Administration is positioned to impose its policy choices on all aspects of the federal government under that wing, which includes the National Institutes of Health (NIH). In an early example of what these policy decisions may look like, the NIH released this statement detailing new policies relating to access to their campus by patients and study participants.

Going forward, noncitizens who do not possess a valid Green Card and who visit the NIH campus must register in advance with the NIH. This rule applies to both first-time visitors and those who had an established relationship with the NIH before 2025. Among other things, affected visitors are now required to disclose their full name, citizenship status, passport information, as well as any visa information if the visitor is from a country from which the United States requires a visa. Citizens of the United States and Green Card holders are not required to disclose this information to the NIH before visiting.

At the bottom of the notice, the NIH acknowledges that while the gathering of this information is for their records, that information will be accessible to other federal agencies. The most obvious implication of this policy change is that the Department of Homeland Security, which is the department under which immigration agencies operate (such as Immigrations and Customs Enforcement (ICE)) theoretically can use the data collected from the NIH to identify fresh targets for prosecution and deportation.

One of the main functions of the NIH is to advance medical science by fostering research. Patients who have exhausted traditional options for treatment can take part in clinical trials that test new, experimental treatments that may offer hope. Insurance is not required to participate in all studies; participants are rather usually paid for their time, and healthy volunteers are often sought as well. As such, the NIH offers benefits to those who cannot otherwise afford to see a doctor, as well as to those who have already tried traditional options for treatment. When one considers that undocumented immigrants are more likely to fall within the lower economic classes and not carry health insurance compared to American citizens, the federal government seems to force an impossible choice: health, or home?

The Trump Administration has been forward in expressing its aim to deport undocumented immigrants en masse. This update in NIH policy comes on the heels of the Administration’s announcement of their intent to create a national registry for undocumented immigrants. However, as a side effect of these policy goals, medical research in the United States may be further hampered by the loss of a valuable resource: volunteers.

The Regression of Drug Policy in Trump’s Punitive Approach to Substance Use 

In an effort to handle what he has stated as a “rampant drug smuggling and overdose death” problem in the United States, Trump has confirmed that new 25 percent tariffs will go into effect on March 4th against Mexico and Canada, with an additional 10 percent tariff against China. Despite a nearly 24 percent drop in fatal overdose deaths, there were still an estimated 61,393 opioid-related deaths in the 12 months ending September 2024. Throughout his campaign, Trump called for an end to the “drug epidemic” through harsher sentencing, and even advocated for the use of the death penalty, for drug dealers. History has shown that harsher sentencing and “crackdowns” on drugs and drug use are ineffective, furthering stigmatization and thus limiting access to treatment and promoting the issue rather than curbing it.

Following Nixon’s implementation of the “war on drugs” in 1971, New York introduced harsh sentencing in 1973, mandating a minimum of 15 years to life for dealers and users. These statutes, known as the “Rockefeller Drug Laws,” were the harshest drug-sentencing measures in the country. This new era of harsh sentencing led to a 1,216 percent increase in state prison populations for drug offenses between 1980 and 2008, which, since its inception, has adversely affected black individuals, who are 3.6 times more likely to be arrested for selling drugs and 2.5 times more likely to be arrest for possessing drugs than white individuals.

In recent years, data has shown that there is no statistically significant relationship between state drug imprisonment rates and drug use, drug overdose deaths, and drug arrests. With the recent decrease in overdose-related deathsincreased access to medication-assisted treatment for substance use disorder, and successes of harm reduction programs (such as naloxone, syringe service programs, safe consumption sites, etc.) the use of harsher sentencing as a tactic to fight drugs and drug use in the United States would be a major setback for the country.

Substance use, while including criminal aspects, should be viewed from a treatment lens, not a punitive perspective. History has shown that mandatory minimums, harsher sentences, and increased arrests do not curb the rate of overdose deaths, but have increased it. One study found that within one week of a “drug bust” local overdose deaths doubled due to users seeking supplies from unfamiliar sources. The United States simultaneously has the highest rate of incarceration, the highest rate of drug use, and the highest rate of drug-related deaths. Punitive approaches do not work and policy experts fear that Trump’s efforts could set the nation back in its attempt to address these issues. Should the United States revert to historically ineffective ways of addressing drug use, the exponential work that has been done could be nullified and the nation’s success in dropping overdose regress. With all of Trump’s latest actions, it is important that we not forget about the 48.5 million Americans who face addiction every day and could be greatly impacted by Trump’s punitive approaches. 

The Future of Medicaid: How Proposed Budget Cuts Could Reshape Healthcare for Millions

Medicaid, the largest health insurance program in the country, provides coverage to over 72 million low-income individuals, people with disabilities, and the elderly. It covers one in five Americans and funds almost half of all births in the United States. Medicaid is also administered by the states and jointly funded by the states and the federal government. The Affordable Care Act (ACA), signed by former President Obama in 2010, gave states the option to expand Medicaid eligibility and had the federal government cover 90% of the costs for the 41 states that took them up on the offer. This expansion has been a bipartisan mission over the past decade, with much of the new enrollment coming from Republican-majority states. However, recent governmental developments threaten to restructure the program in vast ways.

On February 25, the House of Representatives passed a budget resolution designed to extend the 2017 tax cuts while requiring $2 trillion in federal savings. The resolution invokes the House Committee on Energy and Commerce (E&C) to find $880 billion in savings over ten years. E&C has widespread supervision of the U.S. economy with subcommittees focusing on areas such as technology, energy, the environment, and health. At the moment, President Trump has ruled out cuts to Medicare, leaving Medicaid the probable target for cost reductions under the tax-cut bill. 

Congressional Republicans have proposed various ways to accomplish these savings, each having disastrous consequences for states and citizens who rely on Medicaid. One approach is to impose work requirements for non-disabled adults and young children. This policy would require Medicaid recipients to be employed, attend school, or serve as caregivers to maintain coverage. Proponents argue this would encourage workforce participation, reduce taxpayer burdens, and rule out fraud while leaving benefits for those who desperately need and deserve them. However, previous efforts, such as those made in Arkansas during President Trump’s first term, indicate that implementing a Medicaid work requirement can lead to thousands of individuals losing coverage. Currently, Georgia is the only state enforcing such a policy. 

Another option Republicans are considering is lowering the federal percentage of help from 90% under the ACA to the previous standard of 50-70%, The Congressional Budget Office estimates that this could save a total of $561 billion over the next decade. However, this would consequently shift significant costs to states, many of which would be unable to afford the difference. If all 41 states that expanded Medicaid attempted to maintain their current levels of coverage provided for by the ACA, they would need to find an additional $44.3 billion annually to account for the loss in federal funds. Most states would likely therefore roll back the expansion. Moreover, some states, including Arizona, Arkansas, and Indiana, have “trigger laws” in place that automatically roll back Medicaid expansion if federal funding lowers. This could leave approximately 10.8 million Americans newly uninsured. 

Another proposal is to impose a per capita cap on Medicaid funding, restricting federal spending growth per enrollee to the rate of medical inflation. This policy could reduce federal spending by $532 billion to nearly $1 trillion in the next ten years. Supporters argue that a per capita cap can provide lower and more predictable federal costs over time. However, it would also transfer new economic risks to the states. Many states would be pressured to reduce benefits and eligibility. This would likely result in increased numbers of uninsured people, fewer benefits covered for future enrollees, and reduced revenues for healthcare facilities. 

Despite nearly unanimous Republican congressional support, public opposition is strong. A recent poll from Hart Research found that 71% of Trump voters oppose the Medicaid cuts. Even some Republican lawmakers, such as Senator Josh Hawley of Missouri, have asserted their apprehension by filing amendments to prevent Medicaid reductions. As the budget process progresses, Medicaid’s future remains uncertain. Given the widespread reliance on Medicaid for essential healthcare needs, especially in rural communities, any changes to the program could have sweeping consequences for individuals, families, and the healthcare system as a whole.

PBMs, Their Controversy, and Their Future

The debate of whether pharmacy benefit managers (PBMs) are necessary in the healthcare field has been ongoing for years and doesn’t seem to be slowing down. PBMs are essentially middlemen and act as negotiating entities in the prescription drug supply chain. PBMs have the opportunity to set the prices of drugs in various ways. For example, PBMs get discounts directly from drug manufacturers and then sell them to pharmacies, while retaining a portion of the profit. Therefore, pharmacies must price their drugs based on how much they purchase them from pharmacy benefit managers. 

There are many different sides to the debate of whether pharmacy benefit managers are necessary. The Pharmaceutical Care Management Association (PCMA), a national association that represents PBMS, argues that PBMs work to lower the price of prescription drugs for patients and payers. On their website, PCMA states that PBMs save payers and patients an average of $1,040 per person every year. On the other hand, PhRMA argues that patients and payers are paying more than they should because of PBMs. They claim that half of every dollar spent on medicine goes to middlemen and others. 

In recent years, there have been numerous issues surrounding PBMs. In 2023, the Federal Trade Commission (FTC) filed multiple 6(b) motions, a special kind of report to study markets and competitions, against multiple PBMs. Further, in September of 2024, the FTC filed an administrative action alleging that the three largest PBMs, Caremark Rx, Express Scripts, and OptumRx violated Section 5 of the FTC Act by utilizing the rebating system to inflate insulin prices. Following this, in November 2024, the PBMs sued to block the FTC’s administrative action. The PBMs allegedthat the suit should have been brought in federal court. Further, Express Script, one of the PBMs, filed another complaint alleging that the FTC’s b(6) reports on PBMs were biased. Specifically, they argue that the report violates the Administrative Procedure Act (APA) because it is arbitrary and capricious and not in the public interest. However, on February 18, 2025, the Missouri District Court refused to block the proceeding. The court explained that the PBMs were unlikely to succeed in their arguments. Therefore, this case is ongoing and could have major implications for the future of PBMs. The FTC’s case, while it focuses on insulin prices, targets the core of the business model used by PBMs. If they succeed, PBMs will have to change the way they operate, essentially changing the entire industry. On the other hand, if Express Script wins on the b(6) report claims, other PBMs who receive similar reports could be more aggressive with their responses to the FTC. Either way, the conflict between the FTC and PBMs will rage on for years to come.