The landscape of healthcare compliance is continually evolving, shaped by new regulations, court decisions, and societal expectations. A recurring theme running through these current regulations centers around the extent of patients’ rights in regard to their healthcare, while at the same time balancing competing legal concerns. Developments just this year have introduced complexities that healthcare organizations must navigate to ensure compliance, safeguard patient rights, and maintain operational integrity.
1. Impact of post-Dobbs decisions
The Dobbs v. Jackson Women’s Health Organization decision, which overturned Roe v. Wade, has had profound implications for healthcare providers across the United States. States have enacted a variety of laws regarding reproductive health, leading to a patchwork of regulations that healthcare organizations must navigate. Compliance officers and legal teams are tasked with ensuring that their institutions adhere to state-specific laws while also considering the ethical and care standards set forth by professional medical associations. This situation has necessitated a careful review of policies and practices regarding reproductive healthcare services, including counseling, referrals, and emergency care.
Following the Dobbs decision, a number of legal challenges have emerged, further complicating compliance efforts. These include:
Emergency Medical Treatment & Active Labor Act (EMTALA)
EMTALA, enacted in 1986, mandates that hospitals provide necessary treatment to stabilize patients in emergency medical conditions. Post-Dobbs, there has been legal scrutiny on how this federal requirement interacts with state abortion laws, particularly in cases where terminating a pregnancy is necessary to save a patient’s life or health. The U.S. Supreme Court heard arguments in this case in April 2024, and a decision is expected summer of 2024.
Privacy Concerns
With increased legal and societal focus on reproductive health services, concerns about patient privacy and data security have intensified. Court cases addressing the sharing of patient information related to reproductive healthcare without proper consent highlight the need for stringent data protection measures.
Also, on April 22, 2024, The Department of Health and Human Services’ Office for Civil Rights (HHS OCR) issued a Final Rule HIPAA Privacy Rule to Support Reproductive Healthcare to strengthen privacy protections for medical records and health information for women, their family members, and doctors who are seeking, obtaining, providing, or facilitating lawful reproductive health care.
Access to Medication
Lawsuits have been filed in several states challenging restrictions on medication abortion, arguing that these restrictions conflict with FDA regulations. Healthcare providers must monitor these legal developments closely to understand their obligations in prescribing and dispensing medication.
2. “Junk Insurance” Final Rules
HHS, along with the Departments of Labor and Treasury, issued final rules on March 28, 2024 to amend the Affordable Care Act by regulating short-term, limited duration health insurance and requiring health insurance companies to protect the rights of patients. These final rules increase transparency in healthcare coverage and ensure that patients do not mistakenly enroll in short-term insurance plans as a substitute for comprehensive coverage.
3. Nondiscrimination Final Rule & Religious Nondiscrimination Guidance
Healthcare providers must navigate the delicate balance between accommodating employees’ religious and moral objections and ensuring nondiscriminatory patient access to care.
The HHS OCR issued a final rule on March 11, 2024 aimed at safeguarding the rights of conscience as protected by federal statutes, entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes. This rule reinforces protections for healthcare workers who refuse to participate in procedures that conflict with their religious beliefs or moral convictions, while also ensuring that patient access to care is not unduly compromised. Healthcare organizations must balance these protections with nondiscrimination policies, necessitating careful policy drafting and employee training.
The Religious Nondiscrimination FAQs on Patient Visitation at Certain Federally Funded Entities and Facilities document, published January 25, 2024, provides clarity on patient visitation rights, emphasizing the importance of nondiscrimination in visitation policies, including for patients and visitors of diverse, religious backgrounds.
4. CMS Interoperability & Prior Authorization Final Rule
This rule, issued January 17, 2024, represents a significant push towards enhancing patient access to health information and streamlining the prior authorization process. By requiring payers and providers to improve data sharing capabilities, the rule aims to reduce administrative burdens and improve patient care continuity. Healthcare organizations must invest in technology and processes that comply with these new standards, emphasizing data security and patient privacy.
Conclusion
The current legal issues in healthcare compliance present a complex web of challenges for healthcare organizations. From navigating new regulations, such as the Nondiscrimination Final Rule and the CMS interoperability requirements to adapting to legal decisions and ensuring patient rights, healthcare providers must be vigilant and proactive in their compliance efforts. In addition, the post-Dobbs era has ushered in significant legal and compliance challenges for healthcare organizations. Court cases stemming from the decision are actively shaping the healthcare compliance landscape, particularly in the realms of reproductive health, patient privacy, and emergency care. Healthcare providers must navigate these challenges with a keen understanding of legal trends, a commitment to patient rights, and a proactive approach to compliance. By doing so, they can ensure that they not only meet regulatory requirements but also uphold the highest standards of care and ethical practice.
