The Weekly Articles

Approved by Governor Newsom in September 2024, the Equity in Health Care Act: Ensuring Safety and Accountability (AB 3161) amends existing law regarding patient safety events to also require analysis of patient safety events by specific sociodemographic factors (“factors”). Health facilities are required to develop, implement, and comply with a patient safety plan which includes several components, such as a patient safety committee, a reporting system for patient safety events which, per AB 3161, is required to include anonymous reporting options, and a process for facility staff to conduct analyses of patient safety events.  AB 3161 requires that the analyses include certain factors to identify disparities in events.  These factors include age, race, ethnicity, gender identity, sexual orientation, preferred language spoken, disability status, payor, and sex. 

In addition, patient safety plans are required to include a process for addressing racism and discrimination, and its impacts on patient health and safety, that includes, but is not limited to, (i) monitoring sociodemographic disparities in patient safety events and developing interventions to remedy known disparities; and (ii) encouraging facility staff to report suspected instances of racism and discrimination. 

Finally, beginning on January 1, 2026, and biannually thereafter, health facilities are required to submit their patient safety plans to the California Department of Public Health, which will make all submitted plans available to the public online. Failure to submit a plan may result in a fine not to exceed five thousand dollars ($5,000).

California's Attorney General recently released a legal advisory clarifying that existing state laws regarding consumer protection, civil rights, and privacy apply to the use of artificial intelligence (AI) in healthcare. The advisory emphasized that AI-driven decisions must comply with laws related to medical necessity, should not be used to unjustly deny care or reinforce bias, must not override the judgment of physicians, and cannot replace the decision-making of licensed medical professionals. The California Department of Justice indicated that there would be strict oversight and potential enforcement actions for any noncompliance, highlighting the state's commitment to leading the regulation of AI in the healthcare sector.

The Trump Administration recently issued a number of executive orders and proclamations marking a significant shift in immigration enforcement policies, with devastating implications for vulnerable communities. As part of this move, the Department of Homeland Security issued a directive on January 20, 2025 rescinding a 2021 policy that prohibited immigration enforcement actions in or near “protected areas.” By allowing Immigration and Customs Enforcement (ICE) agents to make arrests in previously protected areas like hospitals, schools, and churches, fear has now been sown among the undocumented community. In healthcare, this fear could prevent people from seeking essential medical care, exacerbating chronic/serious conditions and potentially fuel a public health crisis. These policies threaten the health and well-being of countless individuals and undermine the trust essential for effective care delivery.

In December 2024, California Attorney General Rob Bonta issued updated guidance for healthcare facilities and providers regarding immigration. The guidance advises against documenting patients’ immigration status in medical records and emphasizes that while providers should not physically obstruct federal agents, they are under no obligation to assist in enforcement actions. The aim is to protect patient privacy and ensure that individuals seek necessary medical care without fear of deportation.

Hospitals and physicians in California are now navigating the complex interplay between federal enforcement policies and state directives aimed at safeguarding patient rights. Healthcare facilities and physician practices are encouraged to develop protocols for handling interactions with ICE, ensuring compliance with legal requirements while maintaining a commitment to patient confidentiality and care.

Hooper, Lundy & Bookman offered equity partnership to Alicia Macklin and promoted Emily Brinkman to partner, effective January 1, 2025. Congratulations, Alicia and Emily!

Alicia Macklin is a member of the Regulatory Department and Co-Chair of both the Behavioral Health Practice Group and the Health Equity Task Force. She advises a range of inpatient and outpatient behavioral health care providers, and hospital and health systems, on matters involving provider licensing and accreditation, scope of practice, the LPS Act, Medicare and Medi-Cal reimbursement, federal and state privacy and confidentiality requirements, EMTALA, medical staff, peer review, and physician investigations.

Emily Brinkman is a member of the Medical Staff Practice Group, with experience in litigation and regulatory compliance. She has extensive experience litigating medical staff cases on behalf of hospitals, and collaborates with medical staff directors and other executives on physician credentialing and privileging issues. Emily also represents licensed providers in licensing board matters, including investigations, disciplinary hearings, and license applications, including postgraduate training licenses and petitions for reinstatement.

In response to proposed new federal guidelines updating previous guidelines from the Center for Disease Control and Prevention (CDC), the California Department of Public Health (CDPH) issued new interim guidance to health care facilities for work exclusions of Healthcare Personnel (HCPs) with suspected or confirmed respiratory infections. The CDPH interim guidance, announced January 10 in CDPH’s first 2025 All Facilities Letter (AFL 25-1), applies to HCPs with COVID-19, influenza and other acute respiratory viral infections, regardless of whether the HCP has been subject to diagnostic testing for viral pathogens.  AFL 25-1 supersedes AFL 21-08.9

Under the CDPH interim guidance, HCPs with suspected or confirmed respiratory viral infection should:

• not return to work until at least 3 days have passed since onset of symptoms and at least 24 hours have passed with no fever (without use of fever-reducing medicine), symptoms are improving, and the HCP feels well enough to return to work. However, if testing was performed and there are positive results, but the HCP is asymptomatic throughout the infection, the HCP should not return to work until at least 3 days have passed since the first positive test.
• wear a facemask (for those not already required to mask) for source control in all patient care and common areas of the facility for at least 10 days after symptom onset or positive test (if asymptomatic).
• perform frequent hand hygiene.

CDPH also recommends that facilities encourage HCPs to stay up to date on influenza and COVID-19 immunizations.

The interim guidance does not apply to novel viral pathogens, including avian influenza, for which other public health guidance is available. CDPH also notes that the interim guidance does not address management of asymptomatic HCPs with high-risk SARS-CoV-2 exposures, which is also addressed in other CDC interim guidance.

AFL 25-1 can be found at: AFL-25-01

Katie Howells recently went in-house, joining Color Health as corporate counsel.  Color provides accessible healthcare services in critical areas such as cancer.  Katie will continue providing her expertise advising on corporate governance, negotiating agreements, and advising on regulatory issues such as the Anti-Kickback and Stark laws, and patient privacy.  Congratulations Katie!

Hoyt Sze and Margia Corner have recently joined Sheppard Mullin's healthcare team as partners.  Sze and Corner previously served as co-interim deputy general counsels for the University of California.  Hoyt Sze's practice focuses on healthcare investigations and white collar defense.  Margia Corner focuses on Medicare and Medicaid reimbursement and other federal and state regulatory requirements governing health system operations.  Congratulations to Hoyt and Margia!

The recent passage of Senate Bill 729, which requires, effective July 1, 2025, that large group health plans cover fertility services, presents an interesting issue due to the current wait for implementing regulations around Senate Bill 600 (SB 600). SB 600, enacted in 2019, required health care service plans to cover fertility preservation services specifically when a person receives a covered medical service that may cause iatrogenic infertility.  However, the Department of Managed Health Care has not yet issued associated regulations to help plans clarify and operationalize this requirement.

The Weekly will not be published for the next two weeks, December 24 and 31, 2024.  CSHA wishes everyone Happy Holidays and Happy New Year!

Andrea Frey with Hooper Lundy & Bookman welcomed her first child, Lila, on November 27, 2024.  Congratulations Andrea!