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Volume XI, Number 108

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December 2020/January 2021 State Regulatory Report

Below are the most recent health care related regulatory developments as published in the New Jersey Register in December 2020 and January 2021:

  • On December 7, 2020, at 52 N.J.R. 2144(a), the Department of Health published a public notice postponing certificate of need call for applications for additional pediatric intensive care beds in accordance with the provisions of N.J.A.C. 8:33 and N.J.S.A. 26:2H-1 et seq., scheduled for September 1, 2020, until September 1, 2021.

  • On January 4, 2021, at 53 N.J.R. 12(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, proposed to repeal N.J.A.C. 13:35-4.2 (Rule 4.2), which regulates abortions, and to amend N.J.A.C. 13:35-4A (Rule 4A) to remove barriers to abortion care that are unrelated to safety and to ensure abortions are regulated like other office-based surgical and special procedures. This includes proposing advanced practice clinicians (APCs)-namely, advanced practice nurses (APNs), physician assistants (PAs), certified nurse midwives (CNMs), and certified midwives (CMs)-be permitted to perform certain abortions. Proposed Amendments:  J.A.C. 13:35-4A.1 through 4A.12; Proposed New Rule: N.J.A.C. 13:35-4A.19; Proposed Repeal: N.J.A.C. 13:35-4.2.  Comments Due: March 5, 2021.

  • On January 4, 2021, at 53 N.J.R. 81(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Psychological Examiners adopted an amendment to N.J.A.C. 13:42-2.4 regarding degrees earned outside of the United States. It requires individuals who apply for licensure to provide the Board with comprehensive evaluation of their degree performed by the National Register of Health Service Psychologists or a foreign credential evaluation service that is member of the National Association of Credential Evaluation Services (NACES). See N.J.A.C. 13:42-2.4.

  • On January 4, 2021, at 53 N.J.R. 86(a), the Department of Health published the anticipated schedule for receipt of certificate of need applications subject to full review procedures for the period beginning January 1, 2021.

 

Category

Deadline for Submission

Long-term care, specialized ventilator

1/2/21 and annually thereafter

Long-term care, specialized behavior modification

1/2/21 and annually thereafter

Long-term care, pediatric

1/2/21 and annually thereafter

Maternal and child health

1/2/21 and annually thereafter

Pediatric intensive care

9/1/21 and annually thereafter

Psychiatric beds

2/1/21 and every two years thereafter

Rehabilitation beds

3/1/21 and every two years thereafter

Children’s hospital

4/1/22 and every three years thereafter

Transplantation

4/1/22 and every three years thereafter

Mobile intensive care unit

6/1/22 and every three years thereafter

Trauma

6/1/22 and every three years thereafter

Long-term care, general

7/1/22 and every three years thereafter

Home health

7/1/22 and every three years thereafter

Burn center, program, unit

4/1/21 and every five years thereafter

New general hospital

4/1/21 and every five years thereafter

 

  • On January 19, 2021, at 53 N.J.R. 101(a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification 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. Pursuant to this temporary rule waiver/modification, the expiration date of any nurse aide certification scheduled to expire between March 1, 2020 and December 31, 2020 shall be extended until March 19, 2021. Additionally, any certified nurse aide whose certification is scheduled to expire between March 1, 2020 and December 31, 2020 shall be permitted to renew his or certification outside of the two-year renewal window, up to and until March 19, 2021. After March 19, 2021, 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. Effective September 1, 2020 to March 19, 2021.

  • On January 19, 2021, at 53 N.J.R. 101(b), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of the requirement that ambulatory care facilities with licensed mobile vans submit to the Department a service schedule, which includes, but is not limited to, dates, times and address(es) where the licensed mobile van will be temporarily stationed to provide licensed care, or memorandums of understanding between a licensed mobile van and host location. Ambulatory care facilities operating mobile vans may implement the terms of this waiver as necessary until the conclusion of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103. See N.J.A.C. 8:43A-23.3 (c).

  • On January 19, 2021, at 53 N.J.R. 102 (a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of N.J.A.C. 8:43I-2.9(c), which sets the criminal background clearance requirements for individuals seeking certification or recertification as a nurse aide. The Department, through this rule modification, is providing an additional extension of the expiration date of criminal background clearance notifications issued to CNAs and CNA candidates to ensure that there is adequate staffing of CNAs in good-standing at long term care facilities throughout the State. Accordingly, the Department is extending the expiration dates of criminal background clearance notifications issued to CNAs and CNA candidates between November 1, 2019 and June 30, 2020 until March 19, 2021. If full certification is not obtained by March 19, 2021, the notice shall expire, and a new criminal history report must be obtained. See N.J.A.C. 8:43I-2.9

  • On January 19, 2021, at 53 N.J.R. 107(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Dentistry proposed an amendment to N.J.A.C. 13:30-8.18 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:30-8.18 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment N.J.A.C. 13:30-8.18.

  • On January 19, 2021, at 53 N.J.R. 109(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing proposed to amend N.J.A.C. 13:37-7.9A to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:37-7.9A to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. These limitations and requirements apply to certified advanced practice nurses. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment: N.J.A.C. 13:37-7.9A

  • On January 19, 2021, at 53 N.J.R. 112(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Optometrists proposed to amend N.J.A.C. 13:38-2.5 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:38-2.5 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on the prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment: N.J.A.C. 13:38-2.5

  • On January 19, 2021, at 53 N.J.R. 114(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy proposes to readopt N.J.A.C. 13:39A with amendments, repeals, and new rules. Proposed Readoption with Amendments: N.J.A.C. 13:39A; Proposed Repeals and New Rules: N.J.A.C. 13:39A-5.5 and 5A; Proposed New Rules: N.J.A.C. 13:39A-4.3 and 5.2A.

  • On January 19, 2021, at 53 N.J.R. 124(c), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted the amended rule requiring physicians to co-prescribe an opioid antidote under certain circumstances. Adopted Amendment: N.J.A.C. 13:35-7.6.

  • On January 19, 2021, at 53 N.J.R 137(a), the Department of Health published a public notice adopting rule changes that permit the establishment of elective PCTA services with off-site cardiac surgery backup to be reviewed under the expedited CN review process and established rules for submission of CN applications for the provision of elective PCI at hospitals with off-site cardiac surgery back up. See N.J.A.C. 833E-2.17.

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© 2021 Giordano, Halleran & Ciesla, P.C. All Rights Reserved National Law Review, Volume XI, Number 62
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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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