Part 3 of our 2025 New Jersey Regulatory Update highlights additional recently adopted rules and amendments impacting healthcare providers, long-term care facilities, residential operators, and licensed professionals. These updates span a range of operational, licensure, compliance, and resident care considerations, emphasizing the need for regulated entities to review applicable requirements and evaluate whether revisions to policies, procedures, or training are necessary.
To read Part 1 of our update, click here. To read Part 2 of our update, click here.
Medicaid/NJ FamilyCare Provider Electronic Records and Electronic Signature Requirements
On September 15, 2025, the New Jersey Department of Human Services Division of Medical Assistance and Health Services published 57 N.J.R. 2265(a), which adopted a new rule under N.J.A.C. § 10:49-9.9 to set requirements for a Medicaid/NJ FamilyCare provider’s use of electronic medical records and electronic signatures should they choose to use electronic recordkeeping methods or electronic signatures on such records. The rule recognizes electronic means as the original record for documenting the nature and scope of services rendered and supporting the medical necessity of those services. The electronic records must comply with applicable state and federal laws, including HIPAA, and must preserve an audit trail showing any modifications. The full text of the adopted rule can be accessed here.
Provider Participation and Beneficiary Eligibility for Psychiatric Adult Acute Partial Hospital and Partial Hospital Services
On October 20, 2025, the New Jersey Department of Human Services Division of Medical Assistance and Health Services published 57 N.J.R. 2420(a) amending N.J.A.C. §§ 10:52A-1.2, 2.1, 3.1, 3.2, 4.5, 4.11, and 4.12 to address eligibility and provider participation requirements for Psychiatric Adult Acute Partial Hospital (APH) and Partial Hospital services. The amendments removed a Global Assessment of Functioning score as a determining factor in medical necessity for such services. Additionally, provider participation now requires providers to obtain a National Provider Identification number and applicable taxonomy codes for their specialty, which aligns with the federal requirements. The rule also clarifies that beneficiaries may access APH services through multiple pathways, including referral from a screening center or emergency service, transition from an inpatient facility as a step-down level of care, or upon a determination by a psychiatrist or APN that clinical need supports the services. The full text of the adopted amendment and rule can be accessed here.
Presence of Authorized Observers During Provider Examinations and Prohibition on Sexual Misconduct by Pharmacists
On October 20, 2025, the New Jersey Department of Law and Public Safety’s Division of Consumer Affairs, State Board of Medical Examiners published 57 N.J.R. 2422(a), which amended N.J.A.C. § 13:35-6.23 to (i) clarify the role of “Board-mandated observers,” also referred to as “chaperones,” who are distinct from the chaperones that board licensees are required to provide during breast, pelvic, genital, and rectal examinations upon the request of a patient or physician pursuant to N.J.A.C. 13:35-6.23 and (ii) add new requirements for the observers, such as requiring them to be a health care professional licensed by the board or the Board of Nursing, or a certified medical assistant. Physicians are now required to clearly post notice of the right to an observer, provide patients with written notice of that right, confirm the patient has read and understood the notice, and maintain a signed record of the acknowledgment. The physician may decline to conduct an examination or provide treatment for which the examination is necessary if the physician cannot provide an observer or if the patient declines the physician’s request to have an observer present. The full text of the adopted amendment and rule can be accessed here.
On the same date, the division’s State Board of Pharmacy published 57 N.J.R. 2427(a), adopting a new rule under N.J.A.C. § 13:39-1.10. This rule prohibits pharmacists from engaging in sexual contact with patients, soliciting sexual contact from patients or in exchange for pharmaceutical services, engaging in inappropriate sexual discussions with patients, or engaging in sexual harassment or other sexually inappropriate conduct. A patient-pharmacist relationship is considered ongoing unless it has been formally terminated in writing and at least 30 days have passed since the last service or more than six months have elapsed since the last pharmaceutical service. The rule also requires pharmacists to take reasonable measures to prevent the unnecessary exposure of a patient’s unclothed body during the provision of pharmaceutical services, makes violations professional misconduct, provides that patient consent is not a defense, and requires licensees to report suspected violations to the board. The full text of the adopted rule can be accessed here.
Out-of-Pocket Maximums for Insulin, an Epinephrine Autoinjector Device, or a Prescription Asthma Inhaler and Coverage for Hearing Aids and Cochlear Implants
On December 1, 2025, the New Jersey Department of Banking and Insurance’s Office of Life and Health published 57 N.J.R. 2682(a), adopting amendments under N.J.A.C. §§ 11:4-49.3 and 11:24-5.2 and new rules under N.J.A.C. §§ 11:22-5.9B, 5.9C, and 5.9D as well as 11:24A-2B placing a fixed cap on out-of-pocket contributions for a covered person prescribed insulin, an epinephrine autoinjector device, or a prescription asthma inhaler and coverage for equipment and supplies needed for the treatment of diabetes and for hearing aids and cochlear implants.
Specifically, covered persons’ cost-sharing for insulin may not exceed $35 per 30-day supply, prescription asthma inhalers may not exceed $50 per 30-day supply, and prescription epinephrine auto-injector devices may not exceed $25 per 30-day supply. Coverage for these items may not be subject to deductibles. The rule applies to any insurance company, health service corporation, medical service corporation, hospital service corporation, health maintenance organization, prepaid prescription service organization, dental service corporation, dental plan organization that issues health benefits plans, prescription drug plans, and to any organized delivery system.
Additionally, health maintenance organizations must cover medically necessary expenses incurred in the purchase of a hearing aid or cochlear implant and the costs of treatment related to cochlear implants.
The full text of the adopted amendments and rules can be accessed here.
Licensure of Embryo Storage Facilities
On December 15, 2025, the New Jersey Department of Health, Public Health Services Branch, Division of Public Health and Environmental Laboratories, published 57 N.J.R. 2828(a) under the Biobanking Compliance Program, adopting a new rule, N.J.A.C. § 8:77. The rule was implemented as part of a new statute that required the department to license and regulate embryo storage facilities (ESFs).
An ESF is defined as “a facility which cryopreserves and stores human egg, pre-embryos, and embryos for later use in in vitro fertilization, embryo transfer, gamete transfer, pronuclear stage transfer and zygote transfer, and other procedures performed to achieve a pregnancy or pregnancies” and “include[s] the office of a licensed health care provider which stores human eggs, pre-embryos, or embryos.” N.J.S.A. § 26:2A-24.
The rule establishes licensure, operational, recordkeeping, and quality management requirements for ESFs in New Jersey. Facilities must obtain and annually renew a department license, maintain accreditation and applicable FDA registration, and submit to department inspections and oversight.
The rule requires ESFs to implement written policies addressing the safe storage, handling, tracking, disposition, and confidentiality of reproductive tissue, as well as staff training, emergency preparedness, and quality management. Facilities must maintain detailed records, protect client and intended recipient information, report specified incidents and equipment failures to the department, and ensure the integrity and traceability of stored reproductive tissue.
The rule also authorizes the department to take enforcement action, including license suspension, revocation, or denial, for violations that threaten patient safety, reproductive tissue integrity, or compliance with applicable requirements. The full text of the adopted rule can be accessed here.
New Registration and Reporting Requirements for Prescription Drug Supply Chain Entities
On November 20, 2025, the New Jersey Department of Law and Public Safety’s Division of Consumer Affairs published 57 N.J.R. 2865(a), which adopted a new rule under N.J.A.C. § 13:45K regarding the registration of and reporting by five types of entities in the prescription drug supply chain: carriers, manufacturers, pharmacy benefit managers, pharmacy services administrative organizations, and wholesalers.
The rule implements New Jersey’s Prescription Drug Affordability Act by establishing registration, assessment, notification, and reporting requirements for these entities. Reporting entities must register annually with the division, pay applicable assessments, and submit prescription drug pricing, cost, utilization, and reimbursement data to increase transparency regarding prescription drug pricing and its impact on insurance premiums and consumer cost-sharing. The rule also requires manufacturers to report certain drug price increases and new drug or biosimilar introductions and requires reporting entities to certify the accuracy and completeness of submissions under penalty of perjury. The information collected will be used to evaluate prescription drug pricing trends and identify the factors contributing to prescription drug costs throughout the supply chain. The full text of the adopted rule can be accessed here.