• • Home
  • About Our Authors

• Authors

  Frank R. Ciesla
  Email
  
  Beth Christian
  Email
  
  Anjali N. Baxi
  Email
  
  
  Ari G. Burd
  Email
  
  
• 

Revisions to Special Focus Facility Program

November 8, 2022 | No Comments
Posted by Anjali Baxi

In October 2022, Centers for Medicare & Medicaid Services (CMS) made some significant changes to the Special Focus Facility (SFF) program that raise the bar for completion of the program and that increases enforcement actions for nursing homes that fail to demonstrate improvement.

The Affordable Care Act mandated that underperforming nursing homes undergo increased inspection and progressive enforcement actions through the SFF program. Sections 1819(f)(8) and 1919(f)(1) of the Social Security Act require CMS to conduct an SFF program which analyzes nursing homes that demonstrate persistent noncompliance with CMS regulations leading to a substantial quality of care. See 42 U.S.C. §§ 1819(f)(8), 1919(f)(1). The CMS SFF program requires the persistently poor performing facilities selected in each state to be inspected at least once every six months and that enforcement actions are taken when warranted. Despite the current SFF program and demonstrated improvement from certain facilities, CMS has found that some facilities remain on the program by failing to show the necessary improvement needed to graduate from the program. CMS has seen certain facilities graduate from the SFF program only to backslide into a non-complaint state, rendering the facility in question to be placed back on the SFF program. To combat this, CMS has authorized revisions to the SFF program to improve quality of care that residents living in a non-compliant facility receive. Additionally, because of CMS’ belief that staffing levels have a significant impact on quality of care, CMS is advising State Survey Agencies to consider a facility’s staffing level, in addition to its compliance history, when selecting candidates from their state for inclusion into the SFF program.

Effective Date: Immediately (Date of Issuance: Oct. 21, 2022)

Summary of Special Focus Facility Program:

The SFF program has been revised to include:

• Making requirements tougher: CMS is adding a threshold that prevents a facility from exiting the SFF program based on the total number of deficiencies cited. A facility may not graduate from the SFF program without demonstrating systemic improvements in quality.
• Terminating federal funding for facilities that do not improve: CMS is considering all facilities with Immediate Jeopardy (IJ) deficiencies on any two surveys while in the SFF program for discretionary termination from the Medicare and/or Medicaid programs.
• Increasing enforcement actions: CMS is imposing more severe, escalating enforcement remedies for SFF program facilities that have continued noncompliance and little or no demonstrated effort to improve performance. In exercising its discretion to impose progressive enforcement, including discretionary termination on a facility, CMS will consider the following factors:
  • A facility’s efforts to improve performance;
  • The circumstances or details of any noncompliance that occurred; and
  • Situations when discretionary termination may potentially interfere with access to care.
• Incentivizing sustainable improvements: CMS is extending the monitoring period and maintaining readiness to impose progressively severe enforcement actions against nursing homes whose performance declines after graduation from the SFF program.

New Jersey has no facilities that have been newly added to the SFF program as of October 2022; two facilities have completed the SFF program and two facilities have shown improvement within the SFF program. Additionally, New Jersey has four facilities included on the SFF program candidate list. You can access the state-by-state breakdown of facility SFF program placement at CMS Document Ref: QSO-23-01-NH available at https://www.cms.gov/files/document/qso-23-01-nh.pdf.

 

Special Thanks to Trenton Rawdan, Penn State Legal Extern

 

April-July 2022 State Regulatory Developments

July 22, 2022 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in April-July 2022:

April 2022

• On April 4, 2022, at 54 N.J.R. 509(a), Governor Murphy issued an Executive Order updating and clarifying timeframes for requiring covered workers at health care facilities and high-risk congregate settings to be up-to-date with their COVID-19 vaccinations, including having received a booster shot. See Executive Order No. 290 (2022).
• On April 4, 2022, at 54 N.J.R. 511(a), Governor Murphy issued an Executive Order lifting the COVID-19 public health emergency. See Executive Order No. 292 (2022). Executive Order Nos. 111, 112, and 207 (2020), Nos. 252, 253, and 271 (2021), and Nos. 283 and 290 (2022) remain in full force and effect pursuant to the Disaster Control Act, N.J.S.A. App. A:9-33 et seq, except that any civil or criminal immunity related to the COVID-19 response bestowed by Executive Order No. 112 shall not be in effect.
• On April 4, 2022, at 54 N.J.R. 525(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Respiratory Care proposed to readopt the Board of Respiratory Care Rules in N.J.A.C. 13:44F with amendments. Following a thorough review in compliance with Executive Order No. 66 (1978), the Board determined that amendments were necessary to provide regulatory congruence and make practical and comprehensive updates to the Board’s rules. The Board believed that the rules proposed for readoption, as amended, were necessary, reasonable, understandable, and responsive to the purposes for which they were promulgated. See N.J.A.C. 13:44F.
• On April 4, 2022, at 54 N.J.R. 552(a), the Department of Community Affairs, Division of Codes and Standards released a notice of readoption for Continuing Care Retirement Community rules in N.J.A.C. 5:19. The rules are intended to enable the Department of Community Affairs to implement the Continuing Care Retirement Community Regulation and Financial Disclosure Act. See N.J.A.C. 5:19. Effective Date: March 8, 2022. New Expiration Date: March 8, 2029.
• On April 4, 2022, at 54 N.J.R. 620(b), the Department of Human Services, Division of Medical Assistance and Health Services adopted amendments to Transportation Services Rules. The chapter describes the policies and procedures of the New Jersey Medicaid/NJ FamilyCare program regarding transportation services. See N.J.A.C. 10:50.
• On April 4, 2022, at 54 N.J.R. 667(a), the Department of Health, Office of the Commissioner released a notice of grant availability, subject to fund availability, in the Department of Health Directory of Grant Programs.
• On April 18, 2022, at 54 N.J.R. 718(a), the Department of Law and Public Safety, Division of Consumer Affairs published a notice of readoption of N.J.A.C. 13:45B, which establish the standards for the regulation of personnel services.  The chapter includes rules on employment agencies, health care service firms and placement of health care practitioners.  Effective Date:   March 14, 2022 until March 14, 2029.

May 2022

• On May 2, 2022, at 54 N.J.R. 771(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed new rules setting forth the requirements to allow a pharmacy to have licensed pharmacists and registered pharmacy technicians perform limited pharmaceutical functions at a location other than on the premises of a pharmacy. For example, pharmacists and pharmacy technicians may perform data entry of prescription medication information and refill authorizations. The Board believed that the proposed new rules will provide pharmacies greater flexibility in managing prescription processing operations. The proposed rules, however, do not allow the storing or dispensing of any medication from a remote location. The proposed new rules will ensure that any prescription processing functions performed at a remote location (that is, other than on the premises of a pharmacy) are performed by qualified and appropriately trained individuals pursuant to safeguards designed to protect the confidentiality of prescription and patient information. See proposed new rules N.J.A.C. 13:39-4A.
• On May 2, 2022, at 54 N.J.R. 780(b), the Department of Human Services, Catastrophic Illness in Children Relief Fund Commission adopted amendments regarding assistance to families with children’s medical expenses. Specifically, proposed amendments to time periods for measuring expenses and income. See adopted amendments N.J.A.C. 10:155-1.3 and 1.13.
• On May 2, 2022, at 54 N.J.R. 782(a), the Department of Law and Public Safety, Division of Consumer Affairs, Charities Registration Unit adopted amendments to require the most recent IRS filings, except for Schedule B (schedule of donors) to be included in initial and renewal registration statements. This eliminates the requirement to include a schedule of donors under Americans for Prosperity Foundation v. Bonta, 141 S. Ct. 2373 (2021) and Americans for Prosperity Foundation v. Grewal No. 3:19-cv-14228-BRM-LHG (D.N.J. Oct. 2, 2019).  Information for financial reports for the long form registration must now include a statement of functional expenses classified to include fundraising and also a statement of cash flows.  Some sections have been reorganized and recodified.  See N.J.A.C. 13:48-4.1, 4.3, 5.1, and 5.3.  Effective May 2, 2022 and expires November 21, 2024.
• On May 2, 2022, at 54 N.J.R. 792(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners released a notice of action on petition for rulemaking regarding increasing social and cultural competence training for licensed professional counselors. The Board held that three hours of training is a minimum requirement, though three hours is consistent with best practices nationwide and in New Jersey. Additionally, the Board does not offer continuing education on any topic, but rather approves providers who review and present continuing education courses. Finally, the core curriculum of professional counselor training programs at higher learning institutions is set by nationally recognized accrediting agencies. Accordingly, the petition was denied.
• On May 16, 2022, at 54 N.J.R. 855(a), the Department of Health, Public Health Services Branch, Division of HIV, STD, and TB Services, Sexually Transmitted Disease Program proposed new rules regarding Expedited Partner Therapy in the wake of an act concerning treatment of sexually transmitted diseases. The Act, codified at N.J.S.A. 26:4-48.2 through 48.4, authorizes health care professionals to provide, “expedited partner therapy” (EPT), a harm reduction practice by which a health care professional, who diagnoses a patient as having a sexually transmitted infection (STI), provides treatment for the patient’s recent sexual partners without first conducting an examination of the partners. To implement EPT in New Jersey, the Act requires the DOH to develop, and make available to health care professionals in the State, informational materials and guidance concerning the safe and effective provision of EPT, as well as require the Department to establish standards for implementation of the Act, to identify the STIs for which EPT is appropriate, based on guidance from the Centers for Disease Control and Prevention (CDC) of the United States Department of Health and Human Services, and to develop informational materials directed toward health care professionals. The proposed new rules would implement the rulemaking obligations that the Act assigns to the Department. See proposed new rules N.J.A.C. 8:67.
• On May 16, 2022, at 54 N.J.R. 907(b), the Department of Human Services, Division of Mental Health and Addiction Services readopted rules that govern the provision of mental health services at inpatient psychiatric hospital units known as short-term care facilities (STCFs). The rules, which were scheduled to expire on May 21, 2022, delineate general requirements applicable to STCFs, including operational standards regarding admission, assessment, and service planning, provision of services, the termination, transfer, and referral of patients, administration and staffing, quality assurance activities, designation and re-designation, and determination of STCF bed need. Notably, the Department recognizes that while it is readopting these rules before expiration, further rulemaking may be necessary to update these rules to reflect current practices. See readopted rules at N.J.A.C. 10:37G.
• On May 16, 2022, at 54 N.J.R. 920(a), the Department of Health, Office of the Commissioner released a notice of postponement of certificate of need call for transplantation. The Department is in the process of gathering and evaluating data to determine whether there is currently a need for transplantation. Accordingly, it is necessary to delay the call for transplantation to allow the Department sufficient time to complete its evaluation of need and to provide potential applicants and affected parties sufficient time to respond appropriately to a certificate of need call notice in the event the Department determines that a call is appropriate.
• On May 16, 2022, at 54 N.J.R. 921(a), the Department of Human Services, Division of Aging Services, released a notice of request for applications for the Program of All-Inclusive Care for the Elderly (PACE) for Bergen and Passaic Counties (as one service area). The purpose of the notice is to solicit applications from eligible entities to establish a PACE program for Bergen and Passaic Counties. PACE is an innovative program that provides frail individuals age 55 and older with comprehensive medical and social services, coordinated and provided by an interdisciplinary team of professionals in a community-based center and in their homes, thereby helping the program participants delay or avoid admission to long-term care facilities. To participate in the program, an individual must be 55 years of age or older, meet clinical eligibility, be able to live safely in the community at the time of enrollment (with the help of PACE services), and must reside in the service area of the PACE program.  REPLACED BY JULY 5, 2022 ISSUANCES 54 N.J.R. 1323(a) and 1332(a).
• On May 16, 2022, at 54 N.J.R. 930(a), the Department of Human Services, Division of Aging Services, released a notice of request for applications for the Program of All-Inclusive Care for the Elderly (PACE) for Middlesex County. The purpose of the notice is to solicit applications from eligible entities to establish a PACE program for Middlesex County. PACE is an innovative program that provides frail individuals age 55 and older with comprehensive medical and social services, coordinated and provided by an interdisciplinary team of professionals in a community-based center and in their homes, thereby helping the program participants delay or avoid admission to long-term care facilities. To participate in the program, an individual must be 55 years of age or older, meet clinical eligibility, be able to live safely in the community at the time of enrollment (with the help of PACE services), and must reside in the service area of the PACE program.
• On May 16, 2022, at 54 N.J.R. 930(a), the Department of Human Services, Division of Aging Services, released a notice of request for applications for the Program of All-Inclusive Care for the Elderly (PACE) for Somerset County. The purpose of the notice is to solicit applications from eligible entities to establish a PACE program for Somerset County. PACE is an innovative program that provides frail individuals age 55 and older with comprehensive medical and social services, coordinated and provided by an interdisciplinary team of professionals in a community-based center and in their homes, thereby helping the program participants delay or avoid admission to long-term care facilities. To participate in the program, an individual must be 55 years of age or older, meet clinical eligibility, be able to live safely in the community at the time of enrollment (with the help of PACE services), and must reside in the service area of the PACE program.
• On May 16, 2022, at 54 N.J.R. 949(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Marriage and Family Therapy Examiners, released a notice of receipt of petition for rulemaking in response to a petition for rulemaking requesting that the Board amend N.J.A.C. 13:34-13.1 to require that supervisors of licensed associate counselors be professional counselors licensed in New Jersey for at least three years and have an approved clinical supervisor certification. The existing rule requires that supervisors of licensed associate counselors have 4,500 hours of work experience subsequent to holding a clinical license to provide mental health counseling services, and that they have either an approved clinical supervisor credential from the Center for Credentialing and Education of the National Board for Certified Counselors, an equivalent supervisor credential recognized by their respective professional healthcare licensing board, or three graduate credits in clinical supervision from a regionally accredited institution of higher education. In addition to N.J.A.C. 13:34-13.1, petitioner’s request would require an amendment at N.J.A.C. 13:34-10.2, specifically altering the language to show that social workers should not be supervisors of associate counselors, thereby limiting eligibility to be a qualified supervisor of associate counselors to professional counselors.

June 2022

• On June 6, 2022, at 54 N.J.R. 959(a), Governor Murphy issued an Executive Order clarifying COVID-19 vaccine requirements for workers in health care and congregate settings. The order directs covered health care settings subject to the CMS rule to maintain a policy pursuant to Executive Order No. 283 (2022) that requires covered workers to provide adequate proof that they are up to date with their COVID-19 vaccinations according to the following schedule: (a) Unvaccinated covered workers must obtain their primary series of a COVID-19 vaccination pursuant to the timeframes set forth by CMS; and (b) All covered workers must provide adequate proof that they have received their first booster dose by April 11, 2022, or within 3 weeks of becoming eligible for their first booster dose, whichever is later. Additionally, covered health care settings not subject to the CMS Rule and covered high-risk congregate settings must maintain a policy pursuant to Executive Order No. 283 (2022) that requires covered workers to provide adequate proof that they are up to date with their COVID-19 vaccinations according to the following schedule: (c) Unvaccinated covered workers must obtain their first dose of the primary series of a COVID-19 vaccination by February 16, 2022; and (d) All covered workers must provide adequate proof that they are up to date with their COVID-19 vaccination by May 11, 2022; provided however, that as to having received their first booster dose, covered workers must provide adequate proof that they are up to date with their COVID-19 vaccinations by May 11, 2022, or within 3 weeks of becoming eligible for their first booster dose, whichever is later. See Executive Order No. 294 (2022).
• On June 6, 2022, at 54 N.J.R. 1082(a), the Department of Human Services, Division of Family Development issued a notice of administrative change whereby the Department adopted a new rule which increased the rate to be paid for Work First New Jersey/General Assistance individuals in residential care facilities to $1,051.05 monthly. This change became effective January 1, 2022, and is the same in both the amount and effective date as the change in the rate for the same services paid to recipients under the Federal program of Supplemental Security Income. See adopted rule N.J.A.C. 10:90-3.17.
• On June 6, 2022, at 54 N.J.R. 1082(b), the Department of Human Services, Division of Family Development issued a notice of administrative change whereby the Department adopted a new rule which changed the rate of the personal needs allowance (PNA) reserved by the owner or operator for Supplemental Security Income (SSI) recipients and Work First New Jersey/General Assistance recipients living in residential health care facilities and for SSI recipients living in boarding homes. The amended rate is in the amount of at least $ 126.00 per month provided that the rate of the total 2022 Federal Social Security cost-of-living increase is 5.9 percent. No owner or operator or agent thereof shall interfere with the recipient’s retention, use, or control of the personal needs allowance. This change became effective January 1, 2022, for SSI recipients and Work First New Jersey/General Assistance recipients living in residential health care facilities and for SSI recipients living in boarding homes. See adopted rule N.J.A.C. 10:123-3.4.
• On June 6, 2022, at 54 N.J.R. 1105(a), the Department of Health, Office of the Commissioner released a notice of postponement of certificate of need call for home health care services. The Department is unable to provide sufficient advance notice to potential certificate of need applicants and interested parties to either prepare their respective certificate of need applications for home health care services or respond to such applications. The Department is in the process of gathering and evaluating data to determine whether there is currently a need for home health care services. Accordingly, the Department felt it is necessary to delay the call for home health care services to allow it sufficient time to complete its evaluation of need, and to provide potential applicants and affected parties sufficient time to respond appropriately to a certificate of need call notice in the event the Department determines that a call is appropriate
• On June 6, 2022, at 54 N.J.R. 1105(b), the Department of Health, Office of the Commissioner released a notice of action on petition for rulemaking. The Department denied the petition for rulemaking. The petitioner requested the Department amend N.J.A.C. 8:43G-1.2 to define the term, “next of kin,” as used at N.J.A.C. 8:43G-4.1(a)7, to include a close friend or other adult who is familiar with the patient’s health care preferences. The Department denied petitioner’s request to define the term “next of kin” and add it to the definition section at N.J.A.C. 8:43G. The Department stated that the term “next of kin” is generally understood to include a spouse or a blood relative, such as a parent, sibling, or offspring, and may include a relation by marriage. Additionally, the Department determined that absent the continuing judicial oversight created by a guardianship proceeding, the Department would exceed its authority to permit, by rulemaking, individuals who are not related by blood or marriage to make discharge and transfer decisions for a patient who is unable to provide consent. Finally, allowing an interested friend to authorize a patient’s discharge to a facility providing a less acute level of care would simply postpone the need for the appointment of a person with continuing decision-making authority with respect to the patient’s social, medical, and financial needs, when a patient is unlikely to return to full mental capacity.
• On June 20, 2022, at 54 N.J.R. 1117(a), the Department of Human Services, Office of Program Integrity and Accountability proposed amendments, repeals, and new rules to comply with the Department’s Fee-for-Service initiative, the Centers for Medicare and Medicaid Services’ guidelines for funding, Danielle’s Law, P.L. 2003, c. 191 (N.J.S.A. 30:6D-5.1–5.6), and Stephen Komninos’ Law, P.L. 2017, c. 238 (N.J.S.A. 30:6D-9.1 et seq., 30:6D-5.4, and 30:6D-74 et seq.). The notice of proposal constitutes the general physical and program requirements for community residences, also known as group homes, supervised apartments, or supported living, which are licensed by the Department to serve individuals with developmental disabilities. The rules set minimum requirements in the areas of general provisions and licensing procedures, organization and administration, advocacy and rights, service delivery/habitation, health and safety, and fire safety and physical environment. The Department feels that the rulemaking is necessary to implement the Department’s statutory mandate to license community residences for individuals with developmental disabilities. See proposed amendments N.J.A.C. 10:44A-1.1, 1.3, 1.4, 1.9, 1.10, 1.11, 1.12, 2.1 through 2.6, 2.9, 2.10, 3, 4.1, 4.2, 5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.8, 6.1 through 6.10, and 6.12 through 6.17. See proposed repeals and new Rules: N.J.A.C. 10:44A-1.5, 1.6, 1.7, 1.8, 2.7, 2.8, 4.3, and 5.6. See proposed repeal: N.J.A.C. 10:44A Appendix.
• On June 20, 2022, at 54 N.J.R. 1137(a), the Department of Human Services, Office of Program Integrity and Accountability, proposed amendments to rules which establish minimum requirements for the provision of residential services to individuals with developmental disabilities residing in community care residences. The Department proposed amendments to update the rules to be consistent with best practices and to include provisions for the Fee-for-Service Initiative; the Centers for Medicare and Medicaid Services’ guidelines for funding; the Central Registry of Offenders against Individuals with Developmental Disabilities (N.J.S.A. 30:4D-77); P.L. 2017, c. 328 (an act concerning background checks and licensing of certain entities); Stephen Komninos’ Law (P.L. 2017, c. 238, an act placing requirements on adult developmental disability programs); and updated organizational changes. See proposed amendments N.J.A.C. 10:44B-1.3, 1.4, 1.5, 2.1, 2.2, 2.3, 2.4, 2A.1, 2A.2, 3.1, 3.2, 3.3, 3.4, 3.5, 4.1, 4.2, 5.1, 5.2, 6.1, 6.3, 6.4, and 6.5.
• On June 20, 2022, at 54 N.J.R.1146(a), the Department of Human Services, Office of Program Integrity and Accountability proposed amendments to comply with the Department’s Fee-for-Service initiative, the Centers for Medicare and Medicaid Services’ guidelines for funding Home and Community Based Services (42 CFR 441.300 et seq.), and Stephen Komninos’ Law, P.L. 2017 c. 238. The rules constitute the minimum requirements for community residences, also known as group homes or supervised apartments, for persons with head injuries (traumatic brain injuries) that are licensed by the Department. The purpose of the proposed amendments is to protect the health, safety, welfare, and human rights of persons who reside in these residences, and to allow such individuals to develop their fullest potential in an environment that is normalized and supportive. The proposed amendments provide for individualized delivery of services to persons served, the establishment and maintenance of a safe environment, the support and encouragement to undertake dignified risk, and the delineation of personal rights to protect them. The Department feels that the proposed amendments are necessary to implement the Department’s statutory mandate to license community residences for persons with traumatic brain injuries. See proposed amendments N.J.A.C. 10:44C-1.1, 1.3, 1.4, 1.7, 1.8, 1.9, 1.12, 2.1, 2.2, 2.4 through 2.10, 3.2, 3.3, 3.4, 3.6, 4.1, 4.2, 4.3, 4.4, 5.2, 5.5, 5.6, 5.7, 6.1, 6.2, 6.3, 6.5, 6.6, 6.9, 6.13, 6.14, and 6.15. See proposed repeal N.J.A.C. 10:44C-1.5.
• On June 20, 2022, at 54 N.J.R. 1168(a), the Department of Health, Division of Certificate of Need and Licensing issued a notice of readoption which readopted N.J.A.C. 8:33, Certificate of Need: Application and Review Process, which was scheduled to expire on June 18, 2022. The Department made technical changes upon readoption. References to the Department of Health and Senior Services are to be replaced throughout the chapter with the Department of Health pursuant to the renaming of the Department at P.L. 2012, c. 17. In 2012, N.J.S.A. 30:1A-14 transferred to the Division of Aging Services (DoAS), in the Department of Human Services, the powers and duties of the Department of Health and Senior Services that relate to the provision of programs or services for senior citizens, the New Jersey State Commission on Aging, the Division on Aging and Community Services, and any other division relating to senior benefits. The Department is developing rulemaking to revise, update, and reorganize existing N.J.A.C. 8:33, and anticipates filing this rulemaking with the Office of Administrative Law for processing in the ordinary course. However, the Public Health Emergency had necessitated the reallocation of Department personnel and resources to pandemic response activities, which resulted in the Department being unable to finalize the anticipated rulemaking prior to chapter expiration. See readoption with technical changes N.J.A.C. 8:33. Effective Date: May 4, 2022. New Expiration Date: May 4, 2029.
• On June 20, 2022, at 54 N.J.R. 1170(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry adopted an amendment which changes N.J.A.C. 13:30-8.18 to implement P.L. 2021, c. 54, which establishes the circumstances and conditions under which a health care practitioner must issue a prescription for an opioid antidote. In accordance with the new law, a licensed dentist must co-prescribe an opioid antidote whenever the dentist issues a prescription for an opioid drug that is a controlled dangerous substance and one of the following conditions exists: the patient has a history of substance use disorder, the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents (MME), or the patient holds a current, valid prescription for a benzodiazepine that is a Schedule III or Schedule IV controlled dangerous substance. The statutory provisions differ from the Board’s original notice of proposal by requiring the prescription for an opioid antidote whenever an opioid drug is prescribed, instead of when the practitioner continuously prescribes a controlled dangerous substance for the management of chronic pain. Additionally, the new law requires the co-prescribing of an opioid antidote if the patient has a history of substance abuse and modifies the threshold for the morphine milligram equivalents to require the co-prescribing of an opioid antidote where the MME exceeds–rather than equals or exceeds–90 MME. The new law also provides that the prescriber is not required to issue more than one prescription for an opioid antidote to a patient per year but may do so, either upon the patient’s request or when the prescriber determines that there is a clinical or practical need for the additional prescription. To implement the new law, the Board is removing proposed new paragraph (h)8 (and the attendant technical change at paragraph (h)7) and to add new subsection (k). In addition, the Board is recodifying subsections (k) and (l) as new subsections (l) and (m), and changing recodified subsection (l) to reflect the addition of subsection (k). The Board is also changing subsection (a) to include a definition for the term “opioid antidote.” See adopted amendment N.J.A.C. 13:30-8.18.
• On June 20, 2022, at 54 N.J.R. 1171(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Electrologists Advisory Committee adopted amendments and new rules to the Electrologists Advisory Committee Rules. Such changes include (i) Purpose and Scope, (ii) Definitions, (iii) Licensing Requirements for Electrologist, (iv) Licensing Requirements for Electrology Instructor, (v) Application for License: Electrologist, (vi) Licensing Requirements for Office Premises, (vii) License Renewal; Reinstatement: Office Premises, (viii) Infection Prevention Standards, (ix) Posting of Licenses and Required Notices, (x) Examination Requirements; Reexamination, (xi) License Renewal: Electrologist and Electrology Instructor, (xii) License Reactivation: Electrologist and Electrology Instructor, (xiii) License Reinstatement: Electrologist and Electrology Instructor, (xiv) Unlicensed Practice, and (xv) Continuing Education; Programs; Standards See adopted amendments N.J.A.C. 13:35-12.1, 12.2, 12.6 through 12.13, 12.15, and 12.19. See adopted repeal and new rule N.J.A.C. 13:35-12.14. See adopted new rules: N.J.A.C. 13:35-12.10A, 12.14A, and 12.14B.
• On June 20, 2022, at 54 N.J.R. 1174(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing, adopted an amendment which changes N.J.A.C. 13:37-7.9A upon adoption to implement P.L. 2021, c. 54, which establishes the circumstances and conditions under which a health care practitioner must issue a prescription for an opioid antidote. In accordance with the new law, a certified advanced practice nurse must co-prescribe an opioid antidote whenever the advanced practice nurse issues a prescription for an opioid drug that is a controlled dangerous substance and one of the following conditions exists: the patient has a history of substance use disorder, the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents (MME), or the patient holds a current, valid prescription for a benzodiazepine that is a Schedule III or Schedule IV controlled dangerous substance. The statutory provisions differ from the Board’s original notice of proposal by requiring the prescription for an opioid antidote whenever an opioid drug is prescribed, instead of when the practitioner continuously prescribes a controlled dangerous substance for the management of chronic pain. Additionally, the new law requires the co-prescribing of an opioid antidote if the patient has a history of substance abuse and modifies the threshold for the morphine milligram equivalents to require the co-prescribing of an opioid antidote where the MME exceeds–rather than equals or exceeds–90 MME. To implement the new law, the Board is removing proposed new paragraph (f)8 (and the attendant technical change at paragraph (f)7) and to add new subsection (i). In addition, the Board is recodifying subsections (i) and (j) as new subsections (j) and (k), and to change recodified subsection (j) to reflect the addition of subsection (i). The Board is also changing subsection (a) to include a definition for the term “opioid antidote.” See adopted amendment 13:37-7.9A.
• On June 20, 2022, at 54 N.J.R. 1175(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Optometrists adopted an amendment which changes N.J.A.C. 13:38-2.5 to implement P.L. 2021, c. 54, which establishes the circumstances and conditions under which a health care practitioner must issue a prescription for an opioid antidote. In accordance with the new law, a licensed optometrist must co-prescribe an opioid antidote whenever the optometrist issues a prescription for an opioid drug that is a controlled dangerous substance and one of the following conditions exists: the patient has a history of substance use disorder, the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents (MME), or the patient holds a current, valid prescription for a benzodiazepine that is a Schedule III or Schedule IV controlled dangerous substance. The statutory provisions differ from the Board’s original notice of proposal by requiring the prescription for an opioid antidote whenever an opioid drug is prescribed, instead of when the licensee continuously prescribes a controlled dangerous substance for the management of chronic pain. Additionally, the new law requires the co-prescribing of an opioid antidote if the patient has a history of substance abuse and modifies the threshold for the morphine milligram equivalents to require the co-prescribing of an opioid antidote where the MME exceeds–rather than equals or exceeds–90 MME. To implement the new law, the Board is removing proposed new paragraph (f)8 (and the attendant technical change at paragraph (f)7) and adding new subsection (i). In addition, the Board is recodifying subsections (i) and (j) as new subsections (j) and (k), and changing recodified subsection (j) to reflect the addition of subsection (i). The Board is also changing subsection (a) to include a definition for the term “opioid antidote.” See adopted amendment N.J.A.C. 13:38-2.5.
• On June 20, 2022, at 54 N.J.R. 1176(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Polysomnography adopted new rules regarding telemedicine and telehealth. These include the purpose and scope, definitions, standard of care, licensee-patient relationship, provision of health care services through telemedicine or telehealth, records, prevention of fraud and abuse, and privacy and notice to patients. See N.J.A.C. 13:44L-7.
• On June 20, 2022, at 54 N.J.R. 1212(b), the Department of Health, Office of the Commissioner issued a notice of cancellation of certificate of need call for maternal and child health services. On February 4, 2019, the Department issued a certificate of need call for additional Intermediate and Intensive Bassinets in certain counties at 51 N.J.R. 178(a). The Department is in the process of reviewing the applications that were submitted in response to the February 4, 2019 call. Accordingly, the Department found it necessary to cancel the January 1, 2022 certificate of need call for regionalized perinatal services and maternal and child health consortia, in order to allow the Department sufficient time to complete the review of the applications submitted February 4, 2019 certificate of need call applications.
• On June 20, 2022, at 54 N.J.R. 1212(c), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Marriage and Family Therapy Examiners issued a notice of action on petition for rulemaking, in which the Department denied a petition for rulemaking that requested the Board to amend N.J.A.C. 13:34-13.1 to require that supervisors of licensed associate counselors be professional counselors licensed in New Jersey for at least three years and have an approved clinical supervisor certification. Pursuant to N.J.A.C. 13:34-13.1(a), supervisors of licensed associate counselors must have 4,500 hours of work experience subsequent to obtaining a clinical license to provide mental health counseling services. They must also have either an approved clinical supervisor credential from the Center for Credentialing and Education of the National Board for Certified Counselors, an equivalent supervisor credential recognized by their respective professional healthcare licensing board, or three graduate credits in clinical supervision from a regionally accredited institution of higher education. Granting the petition would require amending N.J.A.C. 13:34-13.1(a) to require that supervisors of licensed associate counselors hold both a professional counseling license in New Jersey for at least three years and an approved clinical supervisor certification. Granting the petition would also require amending the definition of “qualified supervisor” at N.J.A.C. 13:34-10.2. The definition of “qualified supervisor” includes professionals licensed to practice professional counseling, marriage and family therapy, psychology, psychiatry, and social work. The petitioner states that the education and training social workers receive do not match the education and training required of a professional counselor and, therefore, social workers are not qualified to serve as supervisors of associate counselors. The petitioner does not address whether professionals licensed to practice marriage and family therapy, psychology, or psychiatry should be permitted to supervise associate counselors. However, the petitioner’s proposed amendment at N.J.A.C. 13:34-13.1 would limit eligibility to supervise associate counselors to professional counselors. Accordingly, granting the petition would require amending N.J.A.C. 13:34-10.2 to remove the references to marriage and family therapists, psychologists, psychiatrists, and social workers from the definition of “qualified supervisor.” The Board affirmed the Professional Counselor Examiners Committee’s decision to deny the petition.

July 2022

• On July 5, 2022, at 54 N.J.R.1299(a), the Department of Health, Health Systems Branch, Division of Certificate of Need and Licensing, Office of Health Care Financings readopted with amendments the Ambulatory Care Facility Assessment. Such changes include (i) Purpose and Scope, (ii) Definitions, (iii) Calculation of Assessments, (iv) Payment of Assessments, (v) Appeal of Assessment, (vi) Annual Report, (vii) Audit of Annual Report, and (vii) Penalties. See readoption with amendments N.J.A.C. 8:31A.
• On July 5, 2022, at 54 N.J.R. 1300(b), the Department of Human Services, Division of Mental Health and Addiction Services issued a notice of readoption regarding the rules at N.J.A.C. 10:35 which govern the provision of mental health services in county psychiatric facilities. The chapter applies to the operation of current county psychiatric facilities or units, and any additional county psychiatric facilities or units that may be so designated by the Department in the future. The rules delineate requirements, including financial and management plans, affiliation agreements, and transfer of patients between regional State and county psychiatric facilities, as well as sanctions and appeals processes for violations of the rules. While the Department is readopting these rules before expiration, it recognized that further rulemaking may be necessary to update these rules to reflect current practices. The Department will continue to review the rules and may consider making substantive amendments prior to the next scheduled expiration. In addition to readopting the existing rules, the Department proposed technical changes throughout N.J.A.C. 10:35. The technical changes include updating the names of county psychiatric facilities, to reflect a 2018 reorganization through which the State psychiatric hospitals were retained by and fall under the operation of the New Jersey Department of Health, and to ensure consistent use of terminology. See readoption with technical changes N.J.A.C. 10:35. Effective Date: May 27, 2022. New Expiration Date: May 27, 2029.
• On July 5, 2022, at N.J.R. 1301(a), the Department of Human Services, Commission for the Blind and Visually Impaired issued a notice of readoption regarding the rules at N.J.A.C. 10:94 which facilitate programing that allow for a range of services that intend to save sight and restore vision, whenever it is possible, for service recipients Statewide. The Department of Human Services (Department) recognized that further rulemaking is necessary to update this chapter to be consistent with best practices. To that end, the Department is considering substantive amendments to be published following this readoption. See readoption N.J.A.C. 10:94. Effective Date: May 31, 2022. New Expiration Date: May 31, 2029.
• On July 5, 2022, at N.J.R. 1302(a), the Department of Human Services, Division of Developmental Disabilities issued a notice of administrative change which announced that the family maintenance standard, medical cost standard, tuition deduction standard, and the cost of care and maintenance rates shall be utilized in the determination of eligibility and the contribution to care and maintenance of individuals residentially placed by the Division of Developmental Disabilities and their legally responsible relatives for the period beginning January 1, 2022. The approved calendar year 2022 patient payment per diem rate for State developmental centers is $ 1,283.00. The approved calendar year 2022 patient payment per diem rate for residential functional services is $ 384.00. These changes are effective January 1, 2022. See N.J.A.C. 10:46D-3.2.
• On July 5, 2022, at 54 N.J.R. 1323(a), the Department of Human Services, Division of Aging Services, released a notice of request for applications for the Program of All-Inclusive Care for the Elderly (PACE) for the Bergen County designated service area. This request for applications replaces the application that was published in the New Jersey Register at 54 N.J.R. 921(a). The purpose of the notice is to solicit applications from eligible entities to establish a PACE program for the Bergen County designated service area. PACE is an innovative program that provides frail individuals age 55 and older with comprehensive medical and social services, coordinated and provided by an interdisciplinary team of professionals in a community-based center and in their homes, thereby helping the program participants delay or avoid admission to long-term care facilities. To participate in the program, an individual must be 55 years of age or older, meet clinical eligibility, be able to live safely in the community at the time of enrollment (with the help of PACE services), and must reside in the service area of the PACE program.
• On July 5, 2022, at 54 N.J.R. 1332(a), the Department of Human Services, Division of Aging Services, released a notice of request for applications for the Program of All-Inclusive Care for the Elderly (PACE) for the Passaic County designated service area. This request for applications replaces the application that was published in the New Jersey Register at 54 N.J.R. 921(a). The purpose of the notice is to solicit applications from eligible entities to establish a PACE program for the Passaic County designated service area. PACE is an innovative program that provides frail individuals age 55 and older with comprehensive medical and social services, coordinated and provided by an interdisciplinary team of professionals in a community-based center and in their homes, thereby helping the program participants delay or avoid admission to long-term care facilities. To participate in the program, an individual must be 55 years of age or older, meet clinical eligibility, be able to live safely in the community at the time of enrollment (with the help of PACE services), and must reside in the service area of the PACE program.
• On July 18, 2022, at 54 N.J.R. 1392(a), the Department of Health, Public Health Services Branch, Division of Epidemiology, Environmental and Occupational Health, Consumer, Environmental, and Occupational Health Services, Public Health and Food Protection Program, adopted N.J.A.C. 8:27-11.2(a) without the language triggering a mandatory inspection by the local health authority following notification of an adverse reaction to a body art procedure. As proposed, N.J.A.C. 8:27-11.2(a) would have required the local health authority to conduct an inspection of a body art establishment every time that establishment submitted an adverse reaction notification pursuant to N.J.A.C. 8:27-4.6. Upon reconsideration, the Department concluded that a mandatory inspection by the local health authority following notification of an adverse reaction to a body art procedure unnecessarily removes discretion from the local health authority to not perform an inspection where one may not be warranted. In addition, the Department determined that mandatory inspections following notification of an adverse reaction may discourage body art establishments from reporting adverse reactions, depriving local health authorities of information that could reveal trends or patterns in connection with adverse reactions that would be valuable in identifying adulterated batches of pigments or supplies, for example. See readoption with amendments N.J.A.C. 8:27. See adopted repeals N.J.A.C. 8:27-4.3 and 4.7. See adopted repeals and new rules N.J.A.C. 8:27-8, 9.1, 11.1, and 11.5. See adopted new rules N.J.A.C. 8:27-4.1, 4.4, 4.8, 4.9 and 8:27 appendix.
• On July 18, 2022, at 54 N.J.R. 1408(a), the Department of Health, Public Services Branch, Division of HIV, STD and TB Services made non-substantial changes on adoptions to HIV Infection Reporting. Such changes include (i) the Department changing the definition of the term, “HIV-related laboratory result,” (ii) the Department adding a revision date for the referenced technical guidance, (iii) the Department providing additional mechanisms by which clinical laboratories may comply with mandatory reporting of HIV-related laboratory test results, and (iv) the Department requiring identification of a patient’s sex at birth and current gender identity, for consistency with CDC reporting requirements. See adopted recodification with amendments N.J.A.C. 8:57-2.1, 2.3, and 2.11 as 8:65-1.1, 1.3, and 3.2, respectively. See adopted new rules N.J.A.C. 8:65-1.2, 1.4, 2, 3.1, and 3.3. See adopted repeals N.J.A.C. 8:57-2.2, 2.4 through 2.10, and 2.12 and 8:57-2 appendices A through G.
• On July 18, 2022, at 54 N.J.R. 1415(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing, adopted new rules to the Power of Attorney and Loan Ban. Such changes include (i) General Requirements of Licensure; License Renewal; Fee Schedule, and (ii) Homemaker-Home Health Aides. See adopted new rules N.J.A.C. 13:37-5.4 and 14.18.
• On July 18, 2022, at 54 N.J.R. 1416(a), the Department of Law and Public Safety, Division of Consumer Affairs published a notice of readoption of N.J.A.C. 13:44G, which establish the standards for the licensing, certification, and regulation of social workers and for the practice of social work. Effective Date: June 13, 2022. New Expiration Date: June 13, 2029.

 

Special thanks to Summer Associate Robert Tuzzio

 

 

March 2022 State Regulatory Developments

April 12, 2022 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in March 2022:

•  On March 7, 2022, at 54 N.J.R. 406(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners proposed an amendment regarding supervised practical experience prior to receiving a Doctoral Degree. This proposed rule would remove the requirement that at least one year of professional experience be completed subsequent to the applicant receiving a doctoral degree. See proposed amendment N.J.A.C. 13:42-4.1.
•  On March 7, 2022, at 54 N.J.R. 449(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy adopted amendments regarding procedures for authorized prescriber ordered or government sponsored immunizations performed by pharmacists, pharmacy interns, or pharmacy externs. It is also regards to the requirement for pharmacists, pharmacy interns, or pharmacy externs to administer influenza vaccine to minors. A licensed pharmacist or pharmacy intern needs to be pre-approved by the Board to administer vaccines and related emergency medications. See adopted amendments N.J.A.C. 13:39-4.21 and 4.21A.
•  On March 7, 2022, at 54 N.J.R. 457(a), the Department of Health, Office of the Commissioner released a notice regarding the cancellation of Certificate of Need call for new specialized long-term care beds for pediatric care.
•  On March 7, 2022, at 54 N.J.R. 457(b), the Department of Health, Office of the Commissioner released a notice regarding the cancellation of Certificate of Need call for new specialized long-term care beds for severe behavior management.
•  On March 7, 2022, at 54 N.J.R. 457(c), the Department of Health, Office of the Commissioner released a notice regarding the cancellation of Certificate of Need call for new specialized long-term care beds for ventilator care.
•  On March 7, 2022, at 54 N.J.R. 458(b), the Department of Health, Office of the Commissioner released a notice regarding Certificate of Need review cycles and submission dates.
•  On March 7, 2022, at 54 N.J.R. 459(b), the Department of Law and Public Safety, Division of Consumer Affairs released a notice regarding a notice of action on petition for rulemaking for the Board of Marriage and Family Therapy Examiners. The rulemaking request includes that the Board improve and increase the level of cultural competence training to ensure counselors are equipped to provide services to clients from diverse backgrounds.
•  On March 21, 2022, at 54 N.J.R. 500(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing release a notice that a moratorium has been placed on the acceptance of new applications for practical nursing programs.

 

Special thanks to Jessica Warwick, Law Student Intern

 

February 2022 State Regulatory Developments

March 8, 2022 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in February 2022:

• On February 7, 2022, at 54 N.J.R. 199(b), the Office of the Governor restated Executive Order No. 277, regarding New Jersey’s Health Care Cost Benchmark Program. For 2023 the healthcare cost growth benchmark is 3.5%, for 2024 3.2%, for 2025 3%, for 2026 2.8%, for 2027 2.8%. See Exec. Order No. 277.
• On February 7, 2022, at 54 N.J.R. 203(a), the Office of the Governor issued Executive Order 280 declaring that a Public Health Emergency, established in Exec Order No. 103, continues to exist in NJ. See Exec. Order No. 280.
• On February 7, 2022, at 54 N.J.R. 205(a), the Office of the Governor issued Executive Order 281 continuing Exec. Orders Nos. 111, 112, and 207. This order also allows Exec. Orders No. 251, 252, 253, 264, and 271 to remain in effect. Additionally, this order extends several regulatory actions taken by the Departments in response to COVID-19, including various waivers. See Exec. Order No. 281.
• On February 7, 2022, at 54 N.J.R. 220(a), the Office of the Governor issued Executive Order 282 terminating the State of Emergency declared in Exec. Order Nos. 278 and 279. See Exec. Order No. 282.
• On February 7, 2022, at 54 N.J.R. 248(a), the Department of Health, Division of Certificate of Need and Licensing, Office of Healthcare Financing proposed the readoption and amendments establishing standards to assess and collect fees applicable to certain categories of licensed ambulatory care facilities based on those facilities’ annual gross receipts. See proposed N.J.A.C. 8:31A.
• On February 7, 2022, at 54 N.J.R. 284(a), the Department of Health, Certificate of Need and Licensing Division, published a notice of action on petition of rulemaking for approval of a nurse aide in long-term care facilities training program and eligibility criteria for instructor/evaluators in training programs for long term care facility nurse aides. See N.J.A.C. 8:39-43.10
• On February 7, 2022, at 54 N.J.R. 285(a), the Department of Law and Public Safety, Division of Consumer Affairs, published a notice of action on petition for rulemaking regarding the Board of Marriage and Family Therapy Examiners, Professional Counselor Examiners Committee. This notice is for a petition received to amend N.J.A.C. 13:34-13.1(d), to permit the Committee to count clinical hours obtained before the submission of the proposed plan of supervision toward the number of supervised hours required to become a licensed counselor. See N.J.A.C. 13:34-13.1.
• On February 7, 2022, at 54 N.J.R 285(b), the Department of Law and Public Safety, Division of Consumer Affairs published a notice of action on petition for rulemaking for the Board of Marriage and Family Therapy Examiners, Professional Counselor Examiners Committee regarding N.J.A.C. 13:34-11.6(a) be amended to permit an applicant to submit proof of passing the required exam within one year of the date of application.
• On February 22, 2022, at 54 N.J.R. 295(a), the Office of the Governor released Executive Order 283 requiring healthcare settings maintain policy that requires employees provide adequate proof of their COVID-19 vaccine, all covered employees must provide proof of a booster shot by February 28, 2022, healthcare settings must require employees undergoing testing continue to test once or twice weekly until they submit proof of full vaccination, and policies adopted pursuant to this order must include a disciplinary process for employees who do not comply. See Exec. Order No. 283.
• On February 22, 2022, various notices were released pertaining to the COVID-19 State of Emergency and P.L. 2021, c.103.
  • At 54 N.J.R. 301(a), the Department of Health released a notice that there is continued relaxation of rules pertaining to the standards for licensure of residential substance use disorder treatment facilities. This notice adds definitions for the term’s “telehealth” and “telemedicine.” This notice allows for counseling services to be administered via telehealth and telemedicine services. See N.J.A.C. 10:161A-1.3 and 10.1.
  • At 54 N.J.R. 301(b), the Department of Health released a notice that there is continued relaxation of rules pertaining to the standards for licensure or outpatient substance use disorder treatment facilities. This notice adds definitions for the term’s “telehealth” and “telemedicine.” Additionally, this notice allows for certain physical examinations to take place via telehealth or telemedicine. It also adds rules regarding drug screening. See N.J.A.C. 10:161B-1.3, 6.3, 9.1, 10.1, 11.6, 11.9, 11.12, 11.13, 12.4, 15.1, and 10:161B.
  • At 54 N.J.R. 305(a), the Department of Human Services released a notice that there is a continued relaxation of the rules pertaining to the Community Mental Health Services Act. This notice adds definitions for “face to face,” “telehealth,” and “telemedicine.” See N.J.A.C. 10:37-5.1.
  • At 54 N.J.R. 306(a), the Department of Human services released a notice that is a modification of the rules pertaining to licensed community residences for adults with mental illness. This notice adds the definitions “face to face,” “signature,” “telehealth,” and “telemedicine.” This notice also states that all staff hired during the pandemic shall complete required training within a reasonable period of time. See N.J.A.C. 10:37A-1.2, 4.1, and 7.3.
  • At 54 N.J.R. 307(a), the Department of Human Services released a notice of continued relaxation of the rules pertaining to community support services for adults with serious mental illness. The notice adds the definitions “face to face,” “telehealth,” and “telemedicine.” See N.J.A.C. 10:37B-1.2 and 5.2.
  • At 54 N.J.R. 307(b), the Department of Human Services released a notice of modification of the rules pertaining to outpatient service standards. This notice defines “face to face,” “signature,” “signed,” “telehealth,” and “telemedicine.” It amends the definition “medication monitoring.” This notice also adds that service plans can be developed by an advanced practice nurse. See N.J.A.C. 10:37E-1.2 and 2.4.
  • At 54 N.J.R. 308(a), the Department of Human Services released a notice of the continued relaxation of rules pertaining to partial care service standards. This notice defines “face to face,” “signature,” signed,” “telehealth,” and “telemedicine.” See N.J.A.C. 10:37F-1.3.
  • At 54 N.J.R. 309(a), the Department of Human Services released a notice of continued relaxation of the rules pertaining to programs of assertive community treatment. This notice defines “face to face,” “telehealth,” and “telemedicine.” N.J.A.C. 10:37J-1.2, 2.5, and 2.8.
• On February 22, 2022, at 54 N.J.R. 333(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners proposed amendment regarding limitations on prescribing, administering, or dispensing of controlled dangerous substances, and special requirements for management of acute and chronic pain. Practitioners must identify in advance psychological co-morbidities that affect decisions of continued opioid therapy use. This revision also consists of establishing conditions for co-prescribing an opioid antidote. See proposed N.J.A.C. 13:35-7.6.
• On February 22, 2022, at 54 N.J.R. 336(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing proposed new rules to prohibit nurses and certified homemaker-home health aides from having power of attorney over patients and from accepting loans from patients. Additionally, if the nurse or aide receive a gift of more than $50 from the patient, they must document it. See proposed N.J.A.C. 13:37-5.4 and 14.18.
• On February 22, 2022, the Department of Health, Certificate of Need and Healthcare Facility Licensure Program readopted with technical changes to the Act concerning transplantation services. See readopted N.J.A.C. 8:33Q.
• On February 22, 2022, the Department of Law and Public Safety, State Board of Marriage and Family Therapy Examiners, Alcohol and Drug Counselor Committee adopted new rules regarding telemedicine and telehealth. This new rule authorizes healthcare providers, who are alcohol and drug counselors, to engage in telemedicine and telehealth. This rule sets forth various other rules alcohol and drug counselors must follow regarding telehealth. See adopted N.J.A.C. 13:34C-7.

 

Special thanks to Jessica Warwick, Law Student Intern

January 2022 State Regulatory Developments

March 8, 2022 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register in January 2022:

• On January 3, 2022, at 54 N.J.R. 1, the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners, proposed amendments that allow for an online administration of the jurisprudence examination which applicants for a license to practice psychology in NJ must take. See proposed N.J.A.C. 13:42-3.1, 3.2, 3.6, 5.1, 5.3, 5.4 and 10.21.
• On January 3, 2022, at 54 N.J.R. 52(a), the Department of Health, Public Health Services Branch Office of Local Public Health readopted licensure of persons for public health positions with technical changes. See readopted N.J.A.C. 8:7.
• On January 3, 2022, at 54 N.J.R. 54(a), the Department of Health, Health Systems Branch, Certificate of Need and Licensing Division, Certificate of Need and Healthcare Facility Licensure Program readopted the standard for licensure of assisted living residences, comprehensive personal care homes, and assisted living programs with technical changes. See readopted N.J.A.C. 8:36.
• On January 3, 2022, at 54 N.J.R. 60(a), the Department of Health, Health Systems Branch, Certificate of Need and Licensing Division, Certificate of Need and Healthcare Facility Licensure Program, readopted the manual of standards for licensing of ambulatory care facilities with technical changes. See readopted N.J.A.C. 8:43A.
• On January 3, 2022, at 54 N.J.R. 65(a), the Department of Health, Integrated Health Branch, readopted and recodified the interim assistance procedures manual with technical changes. See readopted N.J.A.C. 10:38 as 8:133.
• On January 3, 2022, at 54 N.J.R. 73(a), the Department of Banking and Insurance, Division of insurance readopted the health maintenance organizations with technical changes. See readopted N.J.A.C. 11:24.
• On January 3, 2022, at 54 N.J.R. 83(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry adopted the following amendments:
• Amending N.J.A.C. 13:30-1A.4 to reflect that the scope of practice of a Dental Hygienist under general supervision in a school setting may include, upon consent of a parent or guardian, preventative measures including biofilm with prophy paste containing fluoride.
• Amending N.J.A.C. 13:30-8.2 and 8.3 to reflect that the inspection and approval by the Board of Dentistry of offices in which parenteral conscious sedation is performed shall occur every five (5) years, rather than every (6) years. N.J.A.C. 13:30-1A.4, 8.2, and 8.3.
• On January 3, 2022, at 54 N.J.R. 87(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing adopted a new rule regarding exit examinations. This rule requires that nursing programs administer a comprehensive examination at the end of the program. This exam shall not affect the students’ ability to graduate or take a licensing exam. See adopted N.J.A.C. 13:37-1.21.
• On January 3, 2022, at 54 N.J.R. 88(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy adopted amendments regarding opioid warning labels. When a pharmacist dispenses a prescription for an opioid medication, they must affix a warning to the bottle that states “opioid risk of addiction and overdose,” along with other requirements. See adopted N.J.A.C. 13:39-7.12.
• On January 18, 2022, at 54 N.J.R. 115(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Dentistry proposed amendments to N.J.A.C. 13:30-8.18 that would be a substantial changes to limitations on prescribing, administering, or dispensing of controlled dangerous substances, and would provide that when a licensee issues a prescription for an opioid drug that is a controlled dangerous substance to a patient, the licensee shall also issue the patient a prescription for an opioid antidote when: (1) the patient has a history of substance use disorder; (2) the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents; or (3) the patient holds a current, valid prescription for a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance. See proposed N.J.A.C. 13:30-8.18.
• On January 18, 2022, at 54 N.J.R. 117(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing proposed substantial changes regarding limitations on prescribing, administering, or dispensing of controlled dangerous substances, and special requirements for management of acute and chronic pain (co-prescribing opioid antidote). See proposed N.J.A.C. 13:37-7.9A.
• On January 18, 2022, at 54 N.J.R. 118(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey State Board of Optometrists proposed substantial changes regarding limitations on prescribing, administering, or dispensing of controlled dangerous substances, and special requirements for management of acute and chronic pain (co-prescribing opioid antidote). See proposed N.J.A.C. 13:38-2.5.
• On January 18, 2022, at 54 N.J.R. 119(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Polysomnography proposed new rules regarding telemedicine and telehealth. See proposed N.J.A.C. 13:44L-7.
• On January 18, 2022, at 54 N.J.R. 149(a), the Department of Health, New Jersey Healthcare Facilities Financing Authority readopted prevailing wage rates for workers employed in the performance of construction contracts for New Jersey Heath Care Facilities. See readopted N.J.A.C. 8:95.
• On January 18, 2022, at 54 N.J.R. 149(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry adopted new rules regarding telemedicine and telehealth. See adopted N.J.A.C. 13:30-9.
• On January 18, 2022, at 54 N.J.R. 152(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing adopted amendments, adopted a new rule, and adopted a repeal regarding education programs. Changes were made to application for establishment of a new program in nursing, provisional accreditation, faculty responsibility for philosophy/missions, and student learning outcomes, maintaining accreditation, preceptors, renewing accreditation, waiver of on-site visits, changes to a nursing program, and other subsections. See adopted N.J.A.C. 13:37-1.2, 1.3, 1.5, 1.6, 1.7, 1.8, 1.13, 1.14, 1.15, 1.16, 1.18, 1.19; See repeal N.J.A.C. 13:37-1.17; See adopted new rule N.J.A.C. 13:37-1.10A.
• On January 18, 2022, at 54 N.J.R. 156(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy adopted amendments regarding fees for out-of-state pharmacies. These fees include $275 for an application permit, $275 for change of ownership/name, and $275 for change of location. See adopted N.J.A.C. 13:39-1.3.
• On January 18, 2022, at 54 N.J.R. 156(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy adopted amendments regarding the removal of the waiting period to retake the examination for licensure. See adopted N.J.A.C. 13:39-2.2 and 2A.5.
• On January 18, 2022, at 54 N.J.R. 156(c), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy adopted amendments that require the pharmacist to document that counseling was provided or refused at the time of prescription dispensing. See adopted N.J.A.C. 13:39-7.21.
• On January 18, 2022, at 54 N.J.R. 157(a), the Department of Law and Public Safety, Division of Consumer Affairs, Occupational Therapy Advisory Council adopted new rules regarding telemedicine and telehealth. See adopted N.J.A.C. 13:44K-7.

 

Special thanks to Jessica Warwick, Law Student Intern

Most Favored Nation

January 14, 2022 | No Comments
Posted by Frank Ciesla

Over the years I have written about the use of “Most Favored Nation” approach to the pricing of Drugs.

• Saga of Most Favored Nations
• Pharmaceutical Industry Challenges President Trump’s EO Adopting Most Favored Nation Approach
•  Pharmaceutical Price Reduction Approaches
•  Pharmaceutical Importations
• Most Favored Nations
• Prescriptions from Outside the US
• Pharmaceuticals
• Pharmaceutical Pricing: Update to May 17, 2018 Blog
• Pharmaceutical Pricing

Currently there is a nationwide preliminary injunction enjoining the Department of Health and Human Services from implementing the Most Favored Nation Rule.   Given this preliminary injunction, the Most Favored Nation Model was not implemented on January 1, 2021 and will not be implemented without further rulemaking.  The Trump administration started moving in that direction. It now appears that the Biden administration is rejecting that approach in favor of the government negotiating prices. What is not clear is what standard will be adopted and by whom as to how the approved price will be negotiated. As more details become available, we will comment.

October-December 2021 State Regulatory Developments

January 12, 2022 | No Comments
Posted by Anjali Baxi

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021:

• On October 4, 2021, at 53 N.J.R. 1657(a), the Commissioner released a notice regarding Executive Order No. 103, which declared a Public Health Emergency for the state in response to COVID-19. This notice extends the waiver of the continuing education requirements for current active health officers and REHSs who are renewing their license for the 2022 licensing period. See N.J.A.C. 8:7-1.11, 1.12, 1.13, 1.17.
• On October 4, 2021, at 53 N.J.R. 1737(a), the Insurance – Department of Banking and Insurance, Individual Health Coverage Program Board, adopted amendments to N.J.A.C. 11:20, Appendix Exhibits A and B. Exhibits can be reviewed by contacting the New Jersey Individual Health Coverage Program. See adopted N.J.A.C. 11:20.
• On October 4, 2021, at 53 N.J.R. 1738(a), the Insurance – Department of Banking and Insurance, Small Employer Health Benefits Program, adopted amendments to N.J.A.C. 11:21, Appendix exhibits F, G, W, Y, HH, and II. Exhibits can be reviewed by contacting the New Jersey Small Employer Health Benefits Program. See adopted N.J.A.C. 11:21.
• On October 18, 2021, at 53 N.J.R. 1783(a), the Department of Human Services, Division of Medical Assistance and Health Services adopted new rules regarding nursing facility patient care ratio requirements. This new chapter addresses requirements for defined nursing facilities to report information concerning certain revenues and the use of those revenues for the care of the residents. See adopted N.J.A.C. 10:49A.
• On October 18, 2021, at 53 N.J.R. 1788(a), the Department of Human Services, Division of Medical Assistance and Health Services readopted a rule regarding chiropractic services. There are also language changes to the chapter. See readopted N.J.A.C. 10:68.
• On October 18, 2021, at 53 N.J.R. 1791(a), the Department of Human Services, Division of the Deaf and Hard of Hearing, readopted with technical changes a rule regarding the organization of the Division of the Deaf and Hard of Hearing. There are also language changes made to the chapter. See readopted N.J.A.C. 10:150.
• On October 18, 2021, at 53 N.J.R. 1791(c), the Department of Human Services, Division of Aging Services, Office of the State Health Insurance for the Aged and Disabled, readopted a rule regarding the Senior Gold Prescription Program Manual. See readopted N.J.A.C. 10:167B.
• On October 18, 2021, at 53 N.J.R. 1792(a), the Department of Human Services, Division of Aging Services, Office of State Health Insurance for the Aged and Disabled, readopted a rule regarding the provision of pharmaceutical services under the Senior Gold Program. See readopted N.J.A.C. 10:167C.
• On October 18, 2021, at 53 N.J.R. 1808(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, made administrative changes regarding the Cannabis Regulatory Commission. This includes agency name updates, contact information, and addresses. See adopted N.J.A.C. 13:35-7.

 

•  On November 1, 2021, at 53 N.J.R. 1838(b), the Department of Health published a notice of readoption of N.J.A.C. 8:45, the regulations establishing clinical laboratory licensure requirements and fees and fees for services performed by the NJDOH Public Health and Environmental Laboratories. Effective September 29, 2021. The Department is developing a rulemaking to extensively revise, update, and reorganize existing N.J.A.C. 8:45, and anticipates filing this rulemaking with the Office of Administrative Law for processing in the ordinary course.
• On November 1, 2021, at 53 N.J.R. 1840(a), the Department of Human Services, Division of Medical Assistance and Health Services (DMHAS) published a notice of readoption of N.J.A.C. 10:32, addressing advanced directives for mental health care. Effective September 24, 2021. The chapter applies to State psychiatric hospitals and DMHAS services.  DMHAS has identified changes to be made to the rules but are too significant to be made part of this readoption.  The anticipated amendments may include substantial amendments and/or recodifications in part, as may be appropriate, to the chapter to reflect the retention of the State psychiatric hospitals by the Department of Health following the return of the DMHAS to the Department of Human Services in accordance with Reorganization Plan 001-2018. Once the review is completed, a separate rulemaking containing proposed amendments and/or recodifications will be published in the New Jersey Register and a 60-day public comment period will be provided.
• 53 N.J.R. 1840(a), 53 N.J.R. 1841(a), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:37 (Community Mental Health Services Act) with technical amendments. The technical amendments include changes to update the Division’s current table of organization, as well as the current name of the “Division of Mental Health and Addiction Services” and the Division’s address. The change to the Division’s name reflects the merger of the former Division of Mental Health and the former Division of Addiction Services under the Fiscal Year 2010-2011 State Appropriations Act. Additionally, an outdated reference to N.J.A.C. 10:37-12, Children’s Partial Care Programs, is being removed because that subchapter was recodified within N.J.A.C. 10:191, Children’s Partial Care Programs, by the Department in 2007; and N.J.A.C. 10:191 was subsequently recodified to N.J.A.C. 3A:58 by the Department of Children and Families in 2017. Effective October 4, 2021; Technical Changes:  November 1, 2021.
• On November 1, 2021, at 53 N.J.R. 1841(b), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:37E (Outpatient Service Standards) with technical amendments. The technical amendments include changes to update the current name of the “Division of Mental Health and Addiction Services” and changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM). The change to the Division’s name reflects the merger of the former Division of Mental Health and the former Division of Addiction Services pursuant to the Fiscal Year 2010-2011 State Appropriations Act. The changes to DSM references include updates to the current DSM criteria by the American Psychiatric Association (APA), including elimination of the multi-axial system of diagnoses, and correcting a reference to the publishing entity of the DSM to the APA. Effective September 24, 2021; Technical Changes November 2, 2021.
• On November 1, 2021, at 53 N.J.R. 1842(a), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:37F (Partial Care Service Standards) with technical amendments. The technical changes include changes to update the current name of the “Division of Mental Health and Addiction Services” and changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM). The change to the Division’s name reflects the merger of the former Division of Mental Health and the former Division of Addiction Services pursuant to the Fiscal Year 2010-2011 State Appropriations Act. The changes to DSM references include updates to the current DSM edition and criteria by the American Psychiatric Association, including elimination of the multi-axial system of diagnoses. Effective September 24, 2021; Technical Changes November 2, 2021.
• On November 1, 2021, at 53 N.J.R. 1843(c), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of N.J.A.C. 10:58 (Nurse Midwifery Services) with technical amendments. The technical changes include: correcting all references to “Department of Health” to reflect the current name of that Department pursuant to P.L. 2012, c. 17; changing all references to “Medicaid/NJ FamilyCare” to reflect the preferred nomenclature of the program; changing references to “Health Maintenance Organization” to “Managed Care Organization”; correcting contact information for the DMAHS fiscal agent; and changing references to “Health Care Financing Administration” to “Centers for Medicare and Medicaid Services” to reflect the current name of the Federal agency. Effective September 24, 2021; Technical Changes November 2, 2021.
• On November 1, 2021, at 53 N.J.R. 1846(a), the Department of Human Services, Division of Medical Assistance and Health Services published a notice of readoption of New Jersey Care … Special Medicaid Programs Manual. The Manual extends Medicaid eligibility to certain persons not eligible under the provisions at N.J.A.C. 10:69, AFDC-Related Medicaid, or 10:71, Medicaid Only. Effective September 28, 2028. The Department is preparing a notice of proposal with substantive amendments to this chapter to be published following this readoption, which is intended to prevent the chapter from expiring.
• On November 1, 2021, at 53 N.J.R. 1852(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners adopted an amendment of N.J.A.C. 13:42-8.1, regarding Client records: Confidentiality. The amendment requires that a licensee retain the permanent client record for at least 7 years from the date of last entry, unless otherwise provided by law. Records for minors must be kept for seven years from the date of last entry or until the client turns 25 years old, whichever is longer, unless otherwise provided by law.
• On November 1, 2021, at 53 N.J.R. 1866(a), the Department of Health issued a public notice of receipt of petition for rule change to N.J.A.C. 8:39-43.10, approval of a nurse aid in long term care (LTC) facility training program and eligibility criteria for instructor/evaluators in training programs for LTC facility nurse aids. This would alleviate some difficulty in finding instructors for the training programs.
• On November 1, 2021, at 53 N.J.R. 1868(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapists issue a public notice of receipt of petition for rulemaking that requests an amendment to N.J.A.C. 13:34-5.3 to change the name “American Association for Marriage and Family Therapy of New Jersey Inc., (AAMFT-NJ)” to the “New Jersey Association for Marriage and Family Therapy (NJAMFT). This name change was recommended to accurately identify the entity that can approve CE courses and programs.
• On November 15, 2021, at 53 N.J.R. 1920(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Chiropractic Examiners published a notice of readoption of N.J.A.C. 13:44E. Effective October 19, 2021.
• On November 15, 2021, at 53 N.J.R. 1935(a), the Department of Health published a notice for rulemaking requesting certain amendments to N.J.A.C. 8:43G-1.2, Definitions and 4.1, Patient Rights. Specifically, the request is to amend the term “next of kin” and identify a hierarchy of individuals whom a hospital could contact to provide consent for a patient when the patient is unable to consent, has no next of kin, and has not designated an individual to make health care decisions on the patient’s behalf.

 

•  On December 6, 2021, at 53 N.J.R. 1982(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners issued a proposal for a new rule at N.J.A.C. 13:35-6.20A for radiologist assistants performing procedures. The rules include definitions for various levels of supervision and permitted tasks within the scope of the license.
• On December 6, 2021, at 53 N.J.R. 2008(a), the Department of Health issued a notice of readoption of Licensure Standards for Mental Health Programs with technical changes and recodification of N.J.A.C. 10:101 as N.J.A.C. 8:121. Effective Date:  October 20, 2021; Technical Changes December 6, 2021. The Department is making technical changes throughout N.J.A.C. 8:121 to update references throughout the chapter to the Department of Health licensing authority.
• On December 6, 2021, at 53 N.J.R. 2013(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments, adopted a new rule and repealed a rule related to Surgery, Special Procedures, Anesthesia Services Performed in an Office Setting. The new rule permit APNs, midwives and PAs to perform abortion procedures to expand abortion access.  See amended N.J.A.C. 13:35-4A.1-4A.12, adopted new rule N.J.A.C. 13:35-4A.19; repealed N.J.A.C. 13:35-4.2. Effective December 6, 2021.
• On December 6, 2021, at 53 N.J.R. 2050(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Respiratory Care adopted new rules regarding telehealth and telemedicine at N.J.A.C. 13:44F-11. Effective December 6, 2021.
• On December 20, 2021, at 53 N.J.R. 2132(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy proposed to delete N.J.A.C. 13:34-2.2(a)6 to remove the requirement to submit a written plan of supervision as a precondition for licensure as an associate marriage and family therapist. In addition, the Board proposed to add N.J.A.C. 13:34-3.3(k) to specify that it is the responsibility of a qualified supervisor to create a written plan of supervision. In accordance with N.J.S.A. 45:8B-18.2, the proposed amendments to N.J.A.C. 13:34-2.2 and new 3.3(l), specify that the written plan for supervision of the licensed associate marriage and family therapist must be approved by the Board prior to the performance of counseling by the licensed associate marriage and family therapist. There was a 60 day comment period for the proposed rule.
• On December 20, 2021, at 53 N.J.R. 2198(a) the Department of Health, Certificate of Need and Licensing Division, CN & Healthcare Facility Licensure Program readopted with technical amendments, N.J.A.C. 8:33C, the Rules for Regionalized Perinatal Services and Maternal and Child Health Consortia. Effective November 18, 2021, Technical changes December 20, 2021.
• On December 20, 2021, at 53 N.J.R. 2199(a), the Department of Health, Certificate of Need and Licensing Division, CN & Healthcare Facility Licensure Program readopted with technical amendments to N.J.A.C. 8:39, Standards for the Licensure of Long Term Care Facilities. Effective November 18, 2021, Technical changes December 20, 2021. The technical amendments include changes to Department’s name and contact information and references to the change in name and contact information of the State Long Term Care Ombudsman’s Office.
• On December 20, 2021, at 53 N.J.R. 2204(a), the Department of Health, Certificate of Need and Licensing Division, CN & Healthcare Facility Licensure Program readopted with technical amendments to N.J.A.C. 8:43F, Standards for Licensure of Adult Day Health Services Facilities. Effective November 18, 2021, Technical changes December 20, 2021.  The technical amendments include changes to the name of the Department/Division throughout the rules.
• On December 20, 2021, at 53 N.J.R. 2208(a), the Department of Health, Certificate of Need and Licensing Division, published a final rule readopting the Standards for Licensure of Residential Substance Use Disorder Treatment (at N.J.A.C. 10:161A) as N.J.A.C. 8:111. This recodification of the standards from the Department of Human Services Chapter to the Department of Health Chapter is in furtherance of the reorganization of services under each Department.  Effective November 10, 2021, Technical changes December 20, 2021.
• On December 20, 2021, at 53 N.J.R. 2222(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a final rule readopting N.J.A.C. 10:64 (Hearing Aid Services) with technical changes relating to references to Medicaid/NJ FamilyCare and Gainwell Technologies (formerly UNISYS). Effective November 16, 2021, Technical changes December 20, 2021.
• On December 20, 2021, at 53 N.J.R. 2224(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a final rule readopting N.J.A.C. 10:67 (Psychological Services) with technical changes related to agency name and contact information nchanges. The chapter contains rules for related to the provision of psychological services to Medicaid/NJ FamilyCare beneficiaries by psychologists in private practice who are reimbursed on a fee-for-service basis but not for psychologists employed by the State, county or private psychiatric hospitals, independent clinics, or those psychologists who are employed by residential treatment centers under contract with a State agency.
• On December 20, 2021, at 53 N.J.R. 2229(b), the Ophthalmic Dispensers and Ophthalmic Technicians adopted new final rules, amendments and repeals of rules in N.J.A.C. 8:33. The rules relate to the application for apprentice certificates, out of state dispenser applications, and reporting of unlawful conduct.  Effective December 20, 2021.

 Special thanks to Jessica Warwick, Law Student Intern

 

September 2021 State Regulatory Developments

October 12, 2021 | No Comments
Posted by Anjali Baxi

---

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

• On September 7, 2021, at 53 N.J.R. 1418(a), the Office of the Governor released Executive Order No. 252 directing vaccination or testing requirements for workers in health care facilities and high-risk settings. Health care and high-risk congregate settings must retain a policy that requires its workers to provide proof of full COVID-19 vaccination or complete COVID-19 testing one to two times per week. The order addresses what documents may be presented to show proof of vaccination. Additionally, it lists what specific settings and workers are deemed “covered.” See Exec. Order. No. 252.
• On September 7, 2021, at 53 N.J.R. 1440(a), the Department of Health, Public Health Services Branch, Division of HIV, STD, and TB Services, proposed recodification, amendments, new rules, and repeals. The amendments address spelling and language changes, as well as definitional changes and additions. The new rules would add web-based publications that the Department uses for reference. See proposed N.J.A.C. 8:57-2.1, 2.3, 2.11. See proposed N.J.A.C. 8:65-1.2, 1.4, 2, 3.1, 3.3. See proposed N.J.A.C. 8:57-2.2, 2.4 through 2.10, 2.12.
• On September 7, 2021, at 53 N.J.R. 1451(a), the Department of Human Services, Division of Medical Assistance and Health Services, proposed the readoption of the Transportation Services Manual with amendments. See proposed N.J.A.C. 10:50, as well as, proposed repeal of certain sections of the chapter. See proposed N.J.A.C. 10:50-1.8, 1.10, 1.11, 1.12, 1.13.
• On September 7, 2021, at 53 N.J.R. 1490(a), the Commission of the Department of Human Services readopted the Rules of Practice; Petition for Rulemaking, with technical changes. See N.J.A.C. 10:1.
• On September 7, 2021, at 53 N.J.R. 1491(a), the Department of Human Services, Office of Licensing readopted the Standards for Private Licensed Facilities for Persons with Developmental Disabilities. See N.J.A.C. 10:47.
• On September 7, 2021, at 53 N.J.R. 1491(b), the Department of Human Services, Division of Medical Assistance and Health Services readopted Psychiatric Adult Acute Partial Hospital and Partial Hospital Services. See N.J.A.C. 10:52A.
• On September 7, 2021, at N.J.R. 1492(a), the Department of Human Services, Division of Medical Assistance and Health Services readopted Case Management Services with technical changes. See N.J.A.C. 10:73.
• On September 7, 2021 at 53 N.J.R. 1499(a), the Department of Labor and Workforce Development, Division of Wage and Hour Compliance readopted the Notification Concerning Health Benefits Plans. See N.J.A.C. 12:63.
• On September 7, 2021, at 53 N.J.R. 1500(a), the Department of Labor and Workforce Development, Division of Workers’ Compensation readopted the Rules of the Division of Workers’ Compensation. See N.J.A.C. 12:235.
• On September 7, 2021, at 53 N.J.R. 1500(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners readopted the Rules of the State Board of Physical Examiners with amendments. See N.J.A.C. 13:39A. Additionally, repeals and new rules were adopted. See N.J.A.C. 13:39A-5.5, 5A and N.J.A.C. 13:39A-4.3, 5.2A.
• On September 7, 2021, the Department of Labor and Workforce Development, Public Safety and Occupational Safety and Health adopted a special amendment to protect healthcare workers from occupational exposure to COVID-19 in settings where people with COVID-19 are expected to be. Healthcare employers must implement plans to control COVID-19 hazards and reduce transmission in the workplace, along with other rules regarding COVID-19 in the healthcare workplace. See adopted N.J.A.C 12:100-4.2.
• On September 20, 2021, at 53 N.J.R. 1558(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Electrologists Advisory Committee proposed amendments, repeal, and new rules. These changes include definitional updates, reference changes and removal, as well as relocating the renewal and reinstatement provisions that relate to an office premise license. See proposed N.J.A.C. 13:35-12.1, 12.2, 12.6 through 12.13, 12.15, 12.19. See proposed repeal N.J.A.C. 13:35-12:14. See proposed N.J.A.C. 13:35-12.10A, 12.14A, 12.14B.
• On September 20, 2021, at 53 N.J.R. 1562(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed a new rule that will require every pharmacy permit holder to implement a continuous quality improvement program to address prescription errors. See proposed N.J.A.C. 13:39-1.9.
• On September 20, 2021, at 53 N.J.R. 1570(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners adopted amendments, new rules, and repeals that revise the standard for denying a license based on conduct constituting a crime or offense. See adopted N.J.A.C. 13:42-5.3, 10.17, 9.3, 10.4, 10.18, 11.4, 10.18.
• On September 20, 2021, at 53 N.J.R. 1580(a), the Department of Treasury, Cannabis Regulatory Commission, recodified the Department of Health’s rules to account for the creation of the Cannabis Regulatory Commission. See recodification of N.J.A.C. 8:64 as 17:30A.

 

Special thanks to Jessica Warwick, Law Student Intern

 

August 2021 State Regulatory Developments

September 7, 2021 | No Comments
Posted by Anjali Baxi

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

• On August 2, 2021, at 53 N.J.R. 1278(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the Manual for Dental Services. See adopted N.J.A.C. 10:56.
•  On August 2, 2021, at 53 N.J.R. 1278(b), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the Medical Supplier Manual. Additionally, technical changes were made to reflect the current name for the “Department of Health” and “Medicaid/NJ FamilyCare.” See adopted N.J.A.C. 10:59.
•  On August 2, 2021, at 53 N.J.R. 1279(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted Independent Clinical Laboratories. Additionally, technical changes were made to reflect the name of the current Division of Medical Assistance and Health Services fiscal agent. See adopted N.J.A.C 10:61.
•  On August 2, 2021, at 53 N.J.R. 1279(b), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the Medically Needy Program. See adopted N.J.A.C. 10:70.
•  On August 2, 2021, at 53 N.J.R. 1280(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted NJ Family Care. See adopted N.J.A.C. 10:78.
•  On August 2, 2021, at 53 N.J.R. 1280(b), the Department of Human Services, Division of Aging Services, Office of Area Agency on Aging Administration, readopted Adult Day Services Program for Persons with Alzheimer’s Disease or Related Disorders. See adopted N.J.A.C. 10:164A
•  On August 2, 2021, at 53 N.J.R. 1283(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption includes new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:34-6A.
•  On August 2, 2021, at 53 N.J.R. 1285(a), The Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Examiners, Professional Counselor Committee, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption includes new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:34-32.
•  On August 2, 2021, at 53 N.J.R. 1288(a), The Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Physician Assistants Advisory Committee, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption included new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:35-2B.3.
•  On August 2, 2021, at 53 N.J.R. 1290(a), The Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Electrologists Advisory Committee, adopted new rules regarding telemedicine and telehealth, authorizing healthcare providers to engage in telemedicine and telehealth. Additionally, this adoption included new rules to be followed when engaging in telemedicine and telehealth. See adopted N.J.A.C. 13:35-12A.
•  On August 16, 2021, at 53 N.J.R. 1327(a), the Department of Human Services, Division of Medical Assistance and Health Services, proposed readoption and amendments to the Home Care Services chapter. The proposed amendments include definition changes, as well as new rules. These new rules address new billing and payment guidelines. See proposed N.J.A.C. 10:60.
•  On August 16, 2021, at 53 N.J.R. 1378(b), The Department of Health, Health Systems Branch, Divisions of Certificate of Need and Licensing, Certificate of Need and Healthcare Facility Licensure Program, adopted new rules addressing the registration standards for Telemedicine and Telehealth Organizations. See adopted N.J.A.C. 8:53.
•  On August 16, 2021, at 53 N.J.R. 1404(c), the Department of Health, Office of the Commissioner released a notice of grant availability. See https://healthapps.state.nj.us/noticeofgrant/noticegrants.aspx
•  On August 16, 2021, at 53 N.J.R. 1405(c), the Department of Law and Public Safety, Division of Consumer Affairs, released a notice addressing that the State Board of Marriage and Family Therapy Examiners received a petition for rulemaking from the New Jersey Association of Marriage and Family Therapy Legislative Committee. Petitioner requests that the requirement that a plan of supervision be submitted as part of the application for licensure as an associate marriage and family therapist be eliminated from the Code. See N.J.A.C. 13:34-2.2.

 

Special thanks to Jessica Warwick, Law Student Intern

June-July 2021 State Regulatory Developments

August 11, 2021 | No Comments
Posted by Anjali Baxi

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

• On June 7, 2021, at 53 N.J.R. 975(a), the Health Commissioner, released a notice in regards to Executive Order No. 103. This notice addresses the renewal of certified nurse aide certifications. If a CANs certification is set to expire between March 1, 2021 and the end of the Public Health Emergency, shall be permitted to renew their certification until 30 days after the end of the Public Health Emergency. See N.J.A.C. 8:39-43.4, 43.6.

 

• On June 7, 2021, at 53 N.J.R. 1001(a), the Department of Human Services, Division of Mental Health and Addiction Services, adopted new organizational rules in order to better inform the public about what the Division of Mental Health and Addiction does. These new rules improve readability, as well as reflect the retention of the State Psychiatric hospitals. See adopted N.J.A.C. 10:30

 

•  On June 7, 2021, at 53 N.J.R. 1001(b), the Department of Human Services, Division of Medical Assistance and Health Services, adopted amendments addressing podiatry services. Whereas podiatry services are optional in accordance with federal Medicaid laws, New Jersey has decided to provide podiatry services. See adopted N.J.A.C. 10:57.

 

• On June 7, 2021, at 53 N.J.R. 1027(a), the Department of Law and Public Safety, Division of Consumer Affairs, released a notice that a petition has been filed addressing a plan of supervision that is currently required as part of the application to be a licensed marriage and family therapist. See N.J.A.C. 13:34-2.2

 

• On June 21, 2021, at 53 N.J.R. 1041(a), the Office of the Governor, released an executive order extending the Public Health Emergency. See Exec. Order No 240.

 

• On June 21, 2021, at 53 N.J.R. 1047(a), the Office of the Governor released an executive order that rescinds the requirements of Executive order No. 107. Non-profits no longer have to accommodate telework to the maximum extent possible. See Exec. Order No. 243.

 

• On July 6, 2021, at 53 N.J.R. 1131(a), the Office of the Governor released an executive order that ended the COVID-19 Public Health Emergency. However, the State of Emergency remains. See Exec Order No. 244.

 

• On July 6, 2021, at 53 N.J.R. 1145(b), the Department of Human Services, Division of Developmental Disabilities, adopted a rule addressing the family maintenance standard, medical cost standard, tuition deduction, and the cost of care and maintenance rates for individuals residentially placed by the Division of Developmental Disabilities. See N.J.A.C. 10:46D-3.2.

Special thanks to Jessica Warwick, Summer Associate

keep looking »

Add Web Slice

• Join our Mailing List
  Subscribe to Our Feed
• Search for:

• Categories

  • Affordable Care Act
  • Behavioral Health Services
  • Business Associate Agreement
  • CMS
  • Codey Law
  • COVID-19
  • DCA
  • Department of Health
  • Department of Justice
  • Emergency Preparedness Regulations
  • Executive Order 112
  • Fair Labor Standards Act
  • False Claims Act
  • Federal Regulatory Developments
  • Fiscal Cliff
  • Healthcare Reform
  • Healthcare Reform: Provider Issues
  • NJDOBI
  • Office of Inspector General
  • Omnibus Rule
  • OPRA
  • Patient Safety Act
  • Reimbursement Issues
  • State Legislative Developments
  • State Regulatory Developments
  • Superior Court
  • telehealth
  • telemedicine
  • Uncategorized
  • Vendor Requirements

• Recent Posts

  • Revisions to Special Focus Facility Program
  • April-July 2022 State Regulatory Developments
  • March 2022 State Regulatory Developments
  • February 2022 State Regulatory Developments
  • January 2022 State Regulatory Developments

• Bookmarks

  • Center for Medicare and Medicaid Services
  • GH&C Healthcare Law Practice Group
  • Health Care Reform Timeline
  • HHS: Office of Instector General

• Archives

  • November 2022
  • July 2022
  • April 2022
  • March 2022
  • January 2022
  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • March 2021
  • December 2020
  • November 2020
  • October 2020
  • August 2020
  • July 2020
  • May 2020
  • April 2020
  • March 2020
  • January 2020
  • August 2019
  • July 2019
  • June 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • October 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • October 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • November 2010
  • October 2010
  • September 2010
  • August 2010
  • May 2010

• Other GH&C Blogs

  • Kurt's Blog Spot
  • NJ Labor and Employment Law Blog
  • NJ Redevelopment Blog
  • The Remediation Wire