March 27, 2023

Volume XIII, Number 86


March 24, 2023

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April 2021 State Regulatory Developments

Below are the most recent health care related regulatory developments as published in the New Jersey Register in April 2021:

  •  On April 5, 2021 at 53 N.J.R 459(a), the Commissioner of Health modified rule N.J.A.C 8:33E-1.4 and -2.3 pursuant to executive order 103, concerning the minimum volume utilization requirements for invasive cardiac diagnostic facilities, cardiac surgical centers, and physicians practicing at those facilities. Some facilities were unable to meet their volume requirements because of the reduced number of elective procedures as a result of COVID-19. According to this rule:

    • The minimum volume utilization requirement for facilities outlined in N.J.A.C 8:33E-1.4 and -2.3 are waived for the duration of the Public Health Emergency, as long as one quarter of the facility’s reporting cycle is covered by the Public Health Emergency; and

    • Physician volume utilization requirements are waived for any calendar year that the Public Health Emergency was in effect for 90 days or more.

  • On April 5, 2021, at 53 N.J.R. 495(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed a new amendment addressing fees for out-of-State pharmacies to be consistent with the amount assessed to in-State pharmacies. See proposed N.J.A.C 13:39-1.3.

  • On April 5, 2021, at 53 N.J.R. 496(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed an amendment addressing the removal of the one year waiting period currently in place for applicants to retake the exam, who have failed the exams for licensure three or more times. See proposed N.J.A.C. 13:39-2.2 and 2A.5.

  • On April 5, 2021, at 53 N.J.R. 497(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy, proposed a subchapter to require that a warning sticker be placed on any bottle containing a prescription of opioid medication. See proposed 13:39-7.12.

  • On April 5, 2021, at 53 N.J.R. 498(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy, proposed an amendment to remove language that a signature from a patient or caregiver is required when counseling was provided or refused. See proposed N.J.A.C 13:39-7.21.

  • On April 5, 2021, at 53 N.J.R. 538(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Professional Counselor Examiners Committee, adopted a new amendment that changes the requirements for supervisor qualifications. See N.J.A.C. 13:34-10.2. The Second amendment adopted, changes the license renewal and continuing education requirement for professional counselors. See N.J.A.C 13:34-15.2. The third amendment adopted changes signature requirements for minors and information that can be shared with a legal guardian of the minor. See N.J.A.C. 13:34-18.6. The fourth amendment adopted changes requirements for continuing education of Rehabilitation Counselors. See N.J.A.C 13:34-24.2. The fifth amendment adopted addresses who is an authorized representative of a minor in regards to rehabilitation counselors. See N.J.A.C 13:34-27.6. The final amendment adopted, changes the definitions of several terms used within the subchapter concerning parental rights. See N.J.A.C 13:34-31.2.

  • On April 19, 2021, at 53 N.J.R. 579(a), Executive Order No. 231 extended the Public Health Emergency declared originally in Executive Order No. 103.

  • On April 19, 2021, at 53 N.J.R. 605(a), the Department of Human Services, Division of Medical Assistance and Health Services proposed a new chapter addressing that nursing facilities will pay a rebate to the Department under certain circumstances. See proposed N.J.A.C 10:49A.

  • On April 19, 2021, at 53 N.J.R. 611(a), the Department Banking and Insurance, Individual Health Coverage Program Board proposed amendments addressing how much a covered person is required to pay, as well as changes to several definitions with in the law. See proposed N.J.A.C 11:20.

  • On April 19, 2021, at 53 N.J.R. 614(a), the Department for Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry, proposed changes to an amendment addressing the scope of practice of licensed dental hygienists under general supervision and changes to parenteral conscious sedation. See proposed N.J.A.C 13:30-1A.4, 8.2, and 8.3.

  • On April 19, 2021, at 53 N.J.R. 616(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners, proposed an amendment requiring that those who do not pass the licensing exam three times shall complete a remediation course before being permitted to retake the exam again. See Proposed N.J.A.C. 13:39A-5.3.

  • On April 19, 2021, at 53 N.J.R. 619(c), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry adopted several amendments, new subchapters, as well as repealed and replaced one subchapter. Substantial changes were made to this part of the code. These changes addressed the application for licensure to practice dentistry, application for licensure of dental hygienists, application for registration as a dental assistant, applicants for limited teaching certificate in dental school, continuing dental education, advertising, and other general provisions. See N.J.A.C. 13:30-1.2, 1.5, 1A.2, 1A.4, 1A.5, 1A.7, 2.2, 2.3, 2.7, 2.8, 3, 5, 6.2, 8.1, 8.2, 8.3, 8.4, 8.7, 8.8, 8.9, 8.10, 8.26. See N.J.A.C 13:30-8.6. See N.J.A.C 13:30-8.5A, 8.6A, 8.6B, 8.12A.

Special thanks to Jessica Warwick, Summer Associate

© 2023 Giordano, Halleran & Ciesla, P.C. All Rights Reserved National Law Review, Volume XI, Number 188

About this Author

Frank R. Ciesla, Giordano Law Firm Health Care Litigation Health Care Fraud and Abuse Tax Health & Hospital Law
Of Counsel

Mr. Ciesla is Chair Emeritus of the firm's Health Care Law Practice Area. His practice is primarily devoted to Health Care and Government Contracts Law. He counsels clients on legal developments facing healthcare providers in the modern health care environment. Firm clients include hospitals, nursing homes, physicians and physician groups, individual practice associations, home health agencies, ambulance carriers and industry-wide associations.

Mr. Ciesla advises such clients on business structures, mergers and consolidations, joint ventures, reorganization of health care providers...

Beth Christian, Giordano Law firm, Health Care Attorney,Health Care Fraud and Abuse, Cannabis Law, Non-Profit Law

Ms. Christian's practice is devoted to Health Care Law and legal issues facing Health Care facilities licensed professionals and non-profit organizations. She has over twenty years of experience counseling clients on legal issues facing the modern health care and non-profit communities.

Anjali Baxi, Giordano Halleran Law Firm, Healthcare Attorney, New Jersey health Law,Cannabis Law,Government Affairs,Business Transactions, Health Care Law Regulation, Medicare and NJ Medicaid Enrollment

Anjali has been practicing law for 15 years, mainly focused on health care transactional and regulatory matters. She prepares and reviews LOIs, purchase agreements and other transaction documents for health care providers needed for the business transfer and necessary for the transfer of NJDOH and NJDHS licenses and provider numbers. She also reviews agreements required for the day to day operations of health care facilities.

She has counseled skilled nursing, assisted living, adult medical day care, outpatient facility clients and hospitals regarding NJDOH regulatory requirements,...

Ari G. Burd, attorney at Giordano Law Firm, Labor & Employment New Jersey Cannabis Law, Health Care

Ari devotes his time to assisting and defending employers with regard to traditional employment issues. He frequently counsels employers for compliance with New Jersey laws and has extensive transactional and litigation experience.

Ari has litigated employment matters throughout the state, having made appearances in almost every Superior Court in New Jersey, as well as before both Federal District Courts in New Jersey and the Federal and State Courts in New York.  These actions have involved a diverse range of claims such as wrongful discharge, discrimination, harassment,...