This fifth entry to our 2022 Regulatory Update further reviews regulatory changes published this year through the New Jersey Register (N.J.R.) including a new public notice on the amount of “modest meals” for prescribers, new prescribing authority for nurses and the revocation of certain COVID-19 related waivers. Although this is the final installment of this Update, we are certain that more regulations will be finalized before the end of this year.

For more information about this blog post, please contact Ryan L. O’Neill or Labinot Alexander Berlajolli.

DCA Issues Public Notice on Modest Meal Rule for Prescribers

54 N.J.R. 1747(a): The New Jersey Division of Consumer Affairs ("DCA") has published a public notice defining the current dollar limits for “modest meals” accepted by prescribers from pharmaceutical manufacturers. This notice updates rules set by the New Jersey Attorney General, under the authority of N.J.S.A. 45:1-17(b), to regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers. Prescribers, who are not speaking or providing promotional activities, and who accept meals beyond the prescribed “modest” value limits from a pharmaceutical manufacturer, may be liable under N.J.A.C. § 13:45J-1 et seq. for the undue acceptance of a gift or compensation. The current dollar limits for “modest meals” may be found here.

Boards of Nursing and Optometry Amend Regulations to Permit Co-Prescribing of Narcan With Opiates

54 N.J.R. 1174(a): The New Jersey Board of Nursing amended rules regarding the prescription of opioid painkillers by advanced practice nurses ("APNs") to reflect new, limited circumstances, in which a patient may also be prescribed an opioid antidote, such as Narcan. The amended regulation provides an update for the term “opioid antidote,” and also defines the situations in which the simultaneous prescription of opioids and opioid antidotes are appropriate (e.g., a patient with a history of a substance abuse disorder). The updated definitions and amended prescribing standards may be found at N.J.A.C. § 13:37-7.9A.

54 N.J.R. 1175(a): Similarly, the New Jersey Board of Optometry amended rules regarding the prescription of opioid painkillers by optometrists to reflect new, limited circumstances, in which a patient may also be prescribed an opioid antidote, such as Narcan. The updated Board of Optometry regulations may be found at N.J.A.C. § 13:38-2.5.

Board of Polysomnography Adopts Telemedicine and Telehealth Rules

54 N.J.R. 1176(a): The New Jersey Board of Polysomnography has implemented the New Jersey telehealth statutes (N.J.S.A. § 45:1-16 et seq.) by adopting telemedicine and telehealth rules for polysomnographic technologists, technicians, and trainees. The new rules are identical to the telemedicine and telehealth rules already in place for other New Jersey healthcare providers. The rules have been codified at N.J.A.C. § 13:44L-7 et seq.

Board of Nursing Readopts Rules Regarding Power of Attorney and Financial Misconduct

54 N.J.R. 1415(a): The New Jersey Board of Nursing readopted, without change, its regulations regarding powers of attorney and other prohibited forms of financial misconduct between licensees and their patients. These regulations specifically prohibit both nurses and homemaker-home health aides from having power of attorney over a patient or accepting financial loans from patients. Additionally, these regulations require licensees to specifically document any gift or money from a patient over $50 in value. The regulations may be found at N.J.A.C. § 13:37-5.4 for nurses and N.J.A.C. § 13:37-14.18 for homemaker-home health aides.

NJDOH Approves Revocation of Further COVID-19 Rule Waivers

54 N.J.R. 1573(a): The New Jersey Department of Health (“NJDOH”) announced that multiple rule waivers instituted in response to the COVID-19 Public Health Emergency would be revoked effective July 18, 2022. Pursuant to Executive Order 281 and its Appendix, certain rule waivers and regulatory relaxations were granted in order to address unique challenges presented by pandemic-related health challenges and administrative difficulties. Following the termination of the New Jersey COVID-19 Public Health Emergency, via revocation of Executive Order 103, multiple rule waivers were granted a grace period in recognition of ongoing challenges posed by the emergence of new COVID-19 variants. A full list of rule waivers terminated as of July 18, 2022 can be found here.

NJDOH Readopts Ambulatory Care Facility Annual Assessment Regulations

54 N.J.R. 1299(a): NJDOH readopted its regulations relating to its annual assessment reports and fees for ambulatory care facilities by the Division of Certificate of Need and Licensing. Although the provisions were readopted without change, ambulatory care facility administrators should be aware that the annual assessment fees must either be remitted electronically, via http://dohlicensing.nj.gov/, or via mail to: Ambulatory Care Facility Payment Unit, Accounting and Procurement, New Jersey Department of Health, 55 North Willow Street, 6th Floor, PO Box 360, Trenton, NJ 08625-0360. The telephone number for the Ambulatory Care Facility Payment Unit is (609) 376-8530. The readopted regulations may be found at N.J.A.C. § 8:31A-1.1, 2.1, 2.2, 2.3, 3.1, 3.2, and 4.1.

Part 4 of our Regulatory Update focuses on vaccine administration, expanding who can prescribe Narcan, among others.

For more information about this blog post, please contact Ryan L. O’Neill or Labinot Alexander Berlajolli.

Board of Pharmacy Updates Regulations for Pharmacy-Administered Vaccine

54 N.J.R. 449(a): Prompted by the COVID-19 pandemic, the New Jersey Board of Pharmacy ("NJ-BOP") amended regulations governing the administration of government-approved vaccines by pharmacists, pharmacy interns, and pharmacy externs. The updated regulations amend pharmacy permitting requirements under N.J.A.C. §13:39-4.21, setting training, documentation, and supervision requirements for pharmacy administration of government-approved vaccinations. Additionally, this rule update establishes specific criteria for the administration of influenza vaccines to minors, codified at N.J.A.C. § 13:39-4.21A.

Board of Nursing Ends Moratorium on Practical Nursing Program Applications

54 N.J.R. 500(a): Under this Public Notice, the New Jersey Board of Nursing ("NJ-BON") announced that it began accepting new applications for accreditation from New Jersey practical nursing programs. In 2009, the NJ-BON had ceased processing such applications due to concerns relating to the high volume of new applicants. As of February 4, 2022, the NJ-BON, having determined that the need for the moratorium no longer exists, will again begin processing accreditation applications for practical nursing programs.

DMAHS Updates Participation Standards for Non-Emergency Transport Providers

54 N.J.R. 620(b): The New Jersey Department of Human Services – Division of Medical Assistance and Human Services ("DMAHS") readopted and modified rules relating to independent transportation company participation for non-emergency transportation services under the NJ Medicaid/Family Care program. The rules establish participation standards, including credentialing and billing requirements, building upon DMAHS rules requiring all non-emergency medical transportation services to be provided by the transportation broker under contract with the Department of Human Services. This update modifies multiple subchapters under N.J.A.C. § 10:50-1 et seq. to reflect the updated participation standards.

Board of Dentistry Permits Limited Prescription of Narcan to Patients Receiving Opiates

54 N.J.R. 1170(b): The New Jersey Board of Dentistry ("NJ-BOD") amended rules regarding the prescription of opioid painkillers to reflect new, limited circumstances in which a patient may also be prescribed an opioid antidote, such as Narcan. The amended regulation provides an update for the term “opioid antidote,” and also defines the situations in which the simultaneous prescription of opioid and opioid antidote are appropriate (e.g., a patient with a history of a substance abuse disorder). The updated definitions and amended prescribing standards may be found at N.J.A.C. § 13:30-8.18.

Board of Medical Examiners Adopts Rules for Licensure of Electrologists

54 N.J.R. 1171(a): The New Jersey Board of Medical Examiners ("NJ-BOME") has adopted rules governing the licensure and practice of electrologists and electrology instructors within New Jersey. The newly established regulations, overseen in part by the Electrology Advisory Committee, establish standards for the education and licensure of electrologists within the state as well as standards of care for the practice of electrology. The new regulations, in their entirety, are available at N.J.A.C. § 13:35-12.1 et seq.

Part 3 of our New Jersey Regulatory Update continues to review regulatory changes published earlier this year through the New Jersey Register (N.J.R.). The following regulatory rule changes reflect rule relaxations and waivers related to the ongoing COVID-19 pandemic. Accordingly, each relaxation will expire when the COVID-19 New Jersey State of Emergency declared under Executive Order No. 103 (2020) is terminated.

For more information about this blog post, please contact Ryan L. O’Neill or Labinot Alexander Berlajolli.

NJDOH Permits Residential SUD Facilities to Provide Counseling via Telemedicine

54 N.J.R. 301(a): The New Jersey Department of Health (“NJDOH”) has relaxed rules relating to the standards for licensure of residential substance use disorder (“SUD”) treatment facilities. The rule relaxation temporarily allows for substance abuse counseling services to be provided through telehealth/telemedicine modalities. The updates are reflected under N.J.A.C. § 10:161A-1.3, which defines telehealth and telemedicine per N.J.S.A. § 45:1-61 et seq., and N.J.A.C. § 161A-10.1, which provides for substance abuse counseling and supportive services. Interestingly, in December 2021, the NJDOH passed a regulation moving these regulations to N.J.A.C. 8:121 et seq. However, 54 N.J.R. 301(a) amended the old regulations, N.J.A.C. 10:161A-1.3, but not N.J.C.A. 8:12 1 et seq.

NJDOH Revises Rules for Outpatient SUD Treatment and OPT Programs

54 N.J.R. 301(b): The NJDOH relaxed multiple rules relating to the standards for licensure of outpatient SUD treatment facilities. The rule relaxation temporarily allows for substance abuse counseling services, buprenorphine physical examination, and comprehensive biopsychosocial assessments to be provided through telehealth/telemedicine modalities. Additionally, certain random or monthly drug screenings for clinic-based medical maintenance may instead be performed at least eight (8) times per year.

Opioid treatment providers ("OTPS") may follow newly released NJDOH Take-Home Dosing and Delivery Guidelines. Additionally, OTPS must include take-home dosing and service procedures being used in response to COVID-19 in their emergency plan or Continuity of Operations Plan ("COOP") and submit their COOPs to the IME COOP Activation email address at imecoop@ubhc.rutgers.edu with a copy to the State Opioid Treatment Authority, Mr. Adam Bucon, through email at adam.bucon@dhs.nj.gov.

The definitions of telehealth and telemedicine have been adopted per N.J.S.A. § 45:1-61 et seq. The regulations affected by this rule relaxation are N.J.A.C. § 10:161B-1.3, 6.3, 9.1, 10.1, 11.6, 11.9, 11.12, 11.13, 12.4, and 15.1.

NJDOH Expands Telehealth for Multiple Mental Health Service Providers

54 N.J.R. 305(a): The NJDOH has relaxed rules for the provision of community mental health services under the Community Mental Health Services Act. The update reflects an adoption of the terms “face to face,” “telehealth,” and “telemedicine,” as defined under N.J.S.A. § 45:1-61 et seq., to the direct service program elements codified at N.J.A.C. § 10:37-5.1.

54 N.J.R. 307(a): This regulation pertains to community support services for adults with serious mental illnesses.  (N.J.A.C. § 10:37B-1.2) They were updated to define the terms “face to face,” “telehealth,” and “telemedicine,” as provided under N.J.S.A. § 45:1-61 et seq. Additionally, the update reflects a technical change in the staff credentials and responsibilities regulation (N.J.A.C. § 10:37B-5.2) to reflect the reorganization of the crisis intervention training requirements now codified at N.J.A.C. 10:37B-4.4(b)(24).

54 N.J.R. 308(a): Similarly, the NJDOH has adopted the terms “face to face,” “telehealth,” and “telemedicine,” as defined under N.J.S.A. § 45:1-61 et seq. under the regulatory definitions for mental health partial care service providers (N.J.A.C. § 10:37F-1.3). Further, the definition of “signature” and “signed” were updated to include electronic marks, further supporting telehealth/telemedicine options.

54 N.J.R. 309(a): Regulations affecting Programs of Assertive Community Treatment ("PACT") providers were also relaxed to increase telehealth/telemedicine options. PACT services provide comprehensive, integrated rehabilitation, treatment and support services to individuals with serious and persistent mental illness, who have had repeated psychiatric hospitalizations, and who are at serious risk for psychiatric hospitalization. The amended regulations replace in-person meeting requirements with “face to face” and “interacting” language, permitting providers to utilize telehealth/telemedicine modalities to render services (N.J.A.C. § 10:37J-2.5). The regulatory definitions (N.J.A.C. § 10:37J-1.2) have further been amended to reflect the terms “face to face,” “telehealth,” and “telemedicine,” as provided under N.J.S.A. § 45:1-61 et seq.

As we approach the fourth quarter of 2022, it is worth reviewing the regulatory rules that have become final in New Jersey over the approximately past twelve months. Part I of this multi-part series contains several regulatory changes published earlier this year through the New Jersey Register (N.J.R.) that have, or will soon become, active regulations.

For more information about this blog post, please contact Ryan L. O’Neill or Labinot Alexander Berlajolli.

Board of Respiratory Care Adopts Telemedicine and Telehealth Rules

53 N.J.R. 2050(a): The New Jersey State Board of Respiratory Care has implemented the New Jersey telehealth statutes (N.J.S.A. § 45:1-61 et seq.) by adopting telemedicine and telehealth rules for respiratory therapists. The new rules are identical to the telemedicine and telehealth rules already in place for other New Jersey healthcare providers. The rules have been codified at N.J.A.C. § 13:44F-11 et seq.

Board of Medical Examiners Revise Regulations on In-Office Surgical Procedures

53 N.J.R. 2013(a): The New Jersey State Board of Medical Examiners (“BME”) adopted and amended multiple regulations pertaining to surgery, special procedures, and anesthesia services performed in an office setting. Notably, the BME adopted N.J.A.C. § 13:35-4A.19, which states that nothing in the subchapter

shall be construed to preclude practitioners from authorizing advanced practice clinicians to perform minor procedures in the office consistent with their respective scopes of practice and as addressed within their individual collaborating agreements.

Additionally, multiple amendments were made throughout N.J.A.C. § 13:35-4A.1 through 4A.12 (See N.J.A.C § 13:35-4A et seq). Notably, the amendments revise multiple definitions under the regulation, including “moderate sedation,” “early aspiration abortion,” and “office.”

NJDOH Re-Codifies Mental Health Program Under New Section

53 N.J.R. 2008(a): The New Jersey Department of Health (“NJDOH”) has readopted and recodified the regulations relating to licensure standards for mental health programs. Such regulations were formerly codified at N.J.A.C. § 10:190 et seq. Per the new rulemaking, the regulations are now codified at N.J.A.C. § 8:121 et seq. Technical changes principally reflect that these regulations shall now be enforced by the NJDOH Division of Certificate of Need and Licensing.

NJDOH Re-Codifies Residential Substance Use Disorder Treatment Facilities Under New Section

53 N.J.R. 2208(a): The NJDOH readopted and recodified the regulations relating to licensure standards of residential substance use disorder treatment facilities. Such regulations were formerly codified at N.J.A.C. § 10:161A et seq. Per the new rulemaking, the regulations are now codified at N.J.A.C. § 8:111 et seq. Technical changes principally reflect that these regulations shall now be enforced by the NJDOH Division of Certificate of Need and Licensing, as well as updating resource-related information (e.g. references to the latest version of the DSM).

Board of Examiners of Ophthalmic Dispensers and Technicians Regarding Certificate Programs 

53 N.J.R. 2229(b): The New Jersey Board of Examiners of Ophthalmic Dispensers and Ophthalmic Technicians has adopted new rules and regulations regarding applications for an Ophthalmic Dispenser Apprentice Certificate and for an Ophthalmic Technician Apprentice Certificate. The rules establish new standards for applying for these certificates, though the new criteria do not apply to ophthalmic dispenser/technician apprentices or students who began their apprenticeships or coursework prior to 12/20/21. The new regulations may be found at N.J.A.C. § 13:33-1.1, 1.2, 2.1, 2.2, 8.9 and 1A.

Board of Dentistry Amends Scope of Practice for Dental Hygienists

54 N.J.R. 83(a): The New Jersey State Board of Dentistry ("BOD") adopted amendments to the scope of practice regulations for dental hygienists as well as the interval for inspection of permit holders who perform certain forms of sedation. Under the amendments, dental hygienists may now perform the removal of biofilm with prophy paste containing fluoride in a school setting under the general supervision of a licensed dentist. Moreover, the BOD has reduced the inspection interval from every six years to every five years for all dental offices in which parenteral conscious sedation or general anesthesia is conducted. The amended regulations may be found at N.J.A.C. § 13:30-1A.4, 8.2, and 8.3.

Board of Pharmacy Amends Labeling Requirements for Opioids

54 N.J.R. 88(a): The New Jersey State Board of Pharmacy adopted amendments to the labeling regulations regarding the color, font, and positioning of labels specifically affixed to prescriptions for opioid medications. Under the amendments, opioid medication labels must be (i) yellow, red or orange in color; printed in an easily and clearly readable, non-cursive font size of at least 10- point font; and, (iii) affixed to the side or cap of the prescription bottle or to the side of the box that contains the prescription label. The amended regulations may be found at N.J.A.C § 13:39-7.12(e).