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Volume X, Number 299

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July and August 2020 State Regulatory Developments

Here are the most recent health care related regulatory developments as published in the New Jersey Register in July and August 2020:

  • On July 6, 2020, at 52 N.J.R. 1336(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted amendments to existing regulations related to the registration and permit requirements for Graduate Medical Education programs in medicine and podiatry. Many of the changes pertain to foreign medical graduates.  See amended N.J.A.C. 13:35-1.5, 3.11, and 3.11A.

  • On July 6, 2020, at 52 N.J.R. 1338(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing adopted a new rule (N.J.A.C. 13:37-7.10A) that permits advanced practice nurses (“APNs”) to dispense narcotic drugs for maintenance or detoxification treatment as follows:

    • The APN may dispense narcotic drugs for maintenance or detoxification treatment if the advanced practice nurse has met the training requirements of, and is registered pursuant to 21 U.S.C. § 823(G).

    • If the APN is qualified to dispense narcotic drugs for maintenance or detoxification treatment pursuant to the regulation, the APN may dispense such drugs even if his or her collaborating physician has not met the requirements of 21 U.S.C. § 823(G), as long as the joint protocol between the advanced practice nurse and the collaborating physician includes the physician’s written approval for the dispensing of such drugs.

    • An APN may prescribe services for treatment of substance use disorder, pursuant to the joint protocol between the advanced practice nurse and his or her collaborating physician.

  • On July 20, 2020, at 52 N.J.R. 1392(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, issued a notice of proposed rule amendments to permit licensed midwives to administer or facilitate the administration of nitrous oxide for pain relief during the intrapartum and postpartum stages when they are providing services in a health care facility licensed by the New Jersey Department of Health. Proposed amendments to the following rules: N.J.A.C. 13:35-2A.10 and 2A.12.

  • On July 20, 2020, at 52 N.J.R. 1434(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Examiners of Ophthalmic Dispensers and Ophthalmic Technicians, adopted an amendment to N.J.A.C. 13:33-6.1 related to continuing education requirements. Notably, there is a limit on the number of marketing/sales CE credits and a requirement for CEs related to bloodborne pathogens.

  • On August 3, 2020, at 52 N.J.R. 1475(a) the Office of the Governor published Executive Order 162 (2020), which was issued on July 2, 2020 and which extended the public health emergency (PHE) in New Jersey for an additional 30 days.

  • On August 3, 2020, at 52 N.J.R. 1485(a) the Department of Health Commissioner issued a notice of emergency adoption of a rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) of the requirements governing the expiration and renewal of certifications for Certified Nurse Aides (CNAs) under N.J.A.C. 8:39-43.4 and N.J.A.C. 8:39-43.6. The temporary rule waiver/modification extends the expiration date of any nurse aide certification scheduled to expire between March 1, 2020 and August 1, 2020 until September 1, 2020. Additionally, any certified nurse aide whose certification is scheduled to expire between March 1, 2020 and August 1, 2020 shall be permitted to renew his or certification outside of the two-year renewal window, up to and until September 1, 2020. The effective date of the emergency adoption is June 8, 2020 through September 1, 2020.

Since the public health emergency remains ongoing and the processing company for certification and recertification of CNAs, PSI Services, LLC, continues to operate only in a limited capacity, some CNAs whose certifications are due to expire between March 1, 2020 and August 30, 2020 will still be unable to renew their certifications prior to their expiration in compliance with N.J.A.C. 8:39-43.6. Due to these limitations beyond the control of CNAs and in consideration of the need to ensure adequate staffing of CNAs in good-standing at long term care facilities throughout the State, NJDOH Commissioner waived/modified the requirements in N.J.A.C. 8:39-43.4(a) and N.J.A.C. 8:39-43.6(a). This temporary rule waiver/modification supersedes the memorandum issued by the Department on March 26, 2020 regarding the extension of nurse aide certifications.

All CNAs will be required to resume complying with all regular certification requirements set forth in N.J.A.C. 8:39-43.4 and N.J.A.C. 8:39-43.6 as of September 1, 2020.

  • On August 3, 2020, at 52 N.J.R. 1485(b) the Department of Health Commissioner issued a notice of emergency adoption of rule waiver/modification pursuant to Executive Order No. 103 (2020) related to N.J.A.C. 8:40A-5.8(e), which requires the Emergency Medical Technician (EMT) program curriculum to include a ten (10) hour clinical experience. The effective date of the emergency adoption is June 11, 2020 and expires upon the termination of the emergency declaration under EO 103.

N.J.A.C. 8:40A-5.8(e) currently requires that all EMT-Basic training programs include a 10-hour clinical experience in the emergency department of an acute care hospital, or another area related to pre-hospital care that has been approved by the Department. Because most, if not all, acute care hospitals are discontinuing EMT clinical experience training in their emergency departments during the COVID-19 pandemic, NJDOH deemed it is necessary and appropriate to relax the requirement that students complete a 10-hour clinical experience in a hospital emergency department.

Pursuant to this rule waiver and modification, EMT-Basic training programs with actively enrolled students are eligible to replace the 10-hour clinical experience in the emergency department of an acute care hospital with simulation so long as it meets certain requirements, delineated in N.J.A.C. 8:40A-5.8(h), including the development of policies and procedures for social distancing and utilization of PPE.

  • On August 3, 2020, at 52 N.J.R. 1487(a) the Department of Health Commissioner issued a notice of emergency adoption of rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) related to the licensing requirements for laboratory collection stations at N.J.A.C. 8:44-2.14 and the licensing fee for collection stations set out at N.J.A.C. 8:45-1.3. The effective date of the emergency adoption is June 5, 2020 and expires 45 days after the termination of the emergency declaration under EO 103.

Under N.J.A.C. 8:44-2.14, collection stations for laboratories must be licensed by the Department of Health’s Clinical Laboratory Improvement Services (CLIS). To obtain a license for a collection station, a laboratory must submit a completed CL-18 form to CLIS and pay the $200 fee set out at N.J.A.C. 8:45-1.3(a). Each collection station must be separately licensed. Additionally, N.J.A.C. 8:44-2.14(b)(2)-(6) restricts the physical location and layout for collection stations.

Pursuant to this rule waiver/modification, New Jersey licensed clinical laboratories may open affiliated collection stations to collect specimens for COVID-19 testing without completing the collection station licensing process or paying the required fee. Additionally, the temporary collection stations do not need to comply with the location and layout requirements set out at N.J.A.C. 8:44-2.14(b)(2)-(6). This waiver is only applicable to laboratories that are properly licensed with the New Jersey Department of Health pursuant to N.J.A.C. 8:44. Collection stations for specimens unrelated to COVID-19 testing must continue to comply with the licensure and fee requirements set out at N.J.A.C. 8:44-2.14 and N.J.A.C. 8:45-1.3. Clinical laboratories that open a temporary COVID-19 specimen collection station must contact Patricia Jackman at the Department via e-mail.

  • On August 17, 2020, at 52 N.J.R. 1621(a), the Department of Health published a notice of grant availability, subject to fund availability, in the Department of Health Directory of Grant Programs. This includes grants for funding available to hospitals for expansion of COVID-19 testing.  See http://healthapps.state.nj.us/noticeofgrant/noticegrants.aspx.

© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved National Law Review, Volume X, Number 234
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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...

732-741-3900
Beth Christian, Giordano Law firm, Health Care Attorney,Health Care Fraud and Abuse, Cannabis Law, Non-Profit Law
Shareholder

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.

732-219-5485
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
Counsel

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,...

732-741-3900
Ari G. Burd, Shareholder, Giordano Law Firm, Labor & Employment, Cannabis Law, Health Care
Shareholder

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,...

732-741-3900
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