September and October 2020 State Regulatory Developments
November 20, 2020
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in September and October 2020:
- On September 8, 2020, at 52 N.J.R. 1641(a), the Department of Health issued notice of emergency adoption of a rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) of the requirements for applicants to receive certification as a nurse aide in long-term care facilities. See N.J.A.C. 8:39-43.2.
- On September 8, 2020, at 52 N.J.R. 1642(a), the Department of Health issued an emergency adoption of a temporary rule waiver/modification of N.J.A.C. 8:40-1.2 which governs Mobility Assistance Vehicle and Basic Life Support Ambulance Services. The adoption requires MAV and BLS crew members to wear delineated PPE and contains procedures for decontamination of vehicles and infection control training. See N.J.A.C. 8:40-1.2.
- On September 8, 2020, at 52 N.J.R. 1643(a), the Department of Health issued an emergency adoption of a temporary rule waiver/modification of certain rules governing Basic Life Support Services, consistent with N.J.A.C. 8:40-1.4(a) to waive/modify the requirement that EMS transport patients with mild, non-life-threatening COVID-19 symptoms to a hospital in order to preserve PPE and prevent the spread of COVID-19. Specific requirements are at N.J.A.C. 8:40-3.6 and 3.6 Appendices A and B, and 6.4 and 6.4 Appendices A and B.
- On September 8, 2020, at 52 N.J.R. 1652(a) the Department of Health issued an emergency adoption of a temporary rule waiver/modification of the expiration deadlines of Emergency Medical Technician (EMT)-Paramedic certifications at N.J.A.C. 8:41A-4.1, Mobile Intensive Care Nurse (MICN) endorsements at N.J.A.C. 8:41-3.13, and EMT-Paramedic recertifications at N.J.A.C. 8:41A-4.3, as follows:
- The June 30, 2020 expiration date for all valid NJ EMT-Paramedic certifications is extended to December 31, 2020;
- The June 30, 2020 expiration date for MICN endorsements is extended to December 31, 2020; and
- Providers shall be able to complete their recertification requirements for their current credentials up to and including December 31, 2020.
- On September 8, 2020, at 52 N.J.R. 1652(b) the Department of Health issued an emergency adoption of a temporary rule waiver/modification of the expiration deadlines of Emergency Medical Technician (EMT)-Basic certifications at N.J.A.C. 8:40A-7.1 and EMT-Basic recertifications at N.J.A.C. 8:40A-7.5, as follows:
- The June 30, 2020 expiration date for all valid NJ EMT-Basic certifications is extended to December 31, 2020;
- EMT-Basics shall be able to complete their recertification requirements for their current credentials up to and including December 31, 2020.
- On September 8, 2020, at 52 N.J.R. 1655(a) the Department of Health issued an emergency adoption of a temporary rule waiver of N.J.A.C. 8:41A-4.4, which sets forth the requirements for certification of an individual formerly certified as an EMT-Paramedic who has allowed that certification to expire. See N.J.A.C. 8:41A-4.4.
- On September 8, 2020, at 52 N.J.R. 1656(a) the Department of Health issued an emergency adoption of a temporary rule waiver of N.J.A.C. 8:43I-2.9(c), which sets the criminal background clearance requirements for individuals seeking certification or recertification as a nurse aide. The temporary rule states that, notwithstanding subsection (c), criminal background clearance notifications issued to a CNA or CNA candidate between November 1, 2019 and March 31, 2020, are valid for a period of 270 days from the date of issuance of the notice of qualification. If full certification is not obtained by the 270th day following the issuance of the notice of qualification, the notice shall expire, and a new criminal history report must be obtained.
- On September 8, 2020, at 52 N.J.R. 1657(a) the Department of Health issued an emergency adoption of a temporary rule waiver of N.J.A.C. 8:43I-4.9(c), which sets the criminal background clearance requirements for individuals seeking certification or recertification as an assisted living administrator. The rule states that notwithstanding subsection (c), criminal background clearance notifications issued to a certified assisted living administrator or assisted administrator candidate between November 1, 2019 and March 31, 2020, are valid for a period of 270 days from the issuance of the notice of qualification. If full certification is not obtained by the 270th day following the issuance of the notice of qualification, the notice shall expire, and a new criminal history report must be obtained.
- On September 8, 2020, at 52 N.J.R. 1675(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Respiratory Care adopted amendments to the regulations governing respiratory care practitioners. Among other changes, the Board will now permit applicants with associate’s degrees rather than require a B.A. See N.J.A.C. 13:44F.
- On September 21, 2020, at 52 N.J.R. 1778(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners adopted an new rule regarding physical therapist and physical therapist assistant compact privileges. There is a $40 compact privilege fee. See N.J.A.C. 13:39A-1.3 (fee); N.J.A.C. 13:39A-2.6 (new rule).
- On September 21, 2020, at 52 N.J.R. 1778(c), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners adopted amendments to rules related to physical therapist assistants. The amendments require supervising licensed physical therapist sign notes prior to the next visit and review licensed physical therapist assistant plan of care. See N.J.A.C. 13:39A-7.2 and 7.3.
- On September 21, 2020, at 52 N.J.R. 1779(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Psychological Examiners adopted an amendment to the continuing education requirements, for biennial renewal periods beginning on July 1, 2019, requiring at least 1 hour of continuing education in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, addiction, and diversion. See N.J.A.C. 13:42-10.20.
- On September 21, 2020, at 52 N.J.R. 1779(b), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology And Speech-Language Pathology Advisory Committee, adopted an amendment that requires licensees to complete the jurisprudence online orientation as part of the biennial license renewal. See N.J.A.C. 13:44C-4.1.
- On September 21, 2020, at 52 N.J.R. 1780(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology And Speech-Language Pathology Advisory Committee, adopted an amendment that requires Fiber Optic Endoscopic Examination of Swallowing (FEES) only to be performed in a healthcare facility or in the office of of a physician who received training during residency or post-residency in endoscopic examination. FEES may only be performed when a physician who received training during residency or post-residency in endoscopic examination is present. See N.J.A.C. 13:44C-7.2A.
- On October 5, 2020, at 52 N.J.R. 1810(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology And Speech-Language Pathology Advisory Committee, proposed an amendment to permit a licensed audiologist to dispense and fit hearing aids, as long as he or she has completed coursework and clinical training in the dispensing and fitting of hearing aids that meets the requirements established by the Audiology and Speech-Language Pathology Advisory Committee (Committee). See N.J.A.C. 13:44C-7.1.
- On October 19, 2020, at 52 N.J.R. 1890(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners proposed new telemedicine regulations for marriage and family therapists. Proposed New Rule: N.J.A.C. 13:34-6A.
- On October 19, 2020, at 52 N.J.R. 1894(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners in consultation with the Professional Counselor Committee proposed new telemedicine regulations for professional counselors regulated by the Committee. Proposed New Rule: N.J.A.C. 13:34-32.
- On October 19, 2020, at 52 N.J.R. 1897(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners in consultation with the Physician Assistants Advisory Committee proposed and amended rule and new telemedicine regulations for physician assistants. Proposed New Rule: N.J.A.C. 13:35-2C.
- On October 19, 2020, at 52 N.J.R. 1901(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, in consultation with the Electrologists Advisory Committee proposed new telemedicine regulations for electrologists. Proposed New Rules: N.J.A.C. 13:35-12A.
- On October 19, 2020, at 52 N.J.R. 1911(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, State Acupuncture Examining Board, adopted telemedicine regulations for licensed acupuncturists. Adopted New Rules: N.J.A.C. 13:35-9.21 through 9.28.
- On October 19, 2020, at 52 N.J.R. 1913(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, adopted telemedicine regulations for licensed genetic counselors. There are industry comment/regulatory responses in this rulemaking that may require a change genetic counselor’s practices when using telemedicine. Adopted New Rules: N.J.A.C. 13:35-14.19 through 14.26.
- On October 19, 2020, at 52 N.J.R. 1916(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing adopted telemedicine regulations for licensed nurses. Adopted New Rules: N.J.A.C. 13:37-8A.
- On October 19, 2020, at 52 N.J.R. 1918(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners, adopted telemedicine regulations for licensed physical therapy. Adopted New Rules: N.J.A.C. 13:39A-10.
- On October 19, 2020, at 52 N.J.R. 1920(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners, adopted telemedicine regulations for licensed psychotherapists. There is lengthy comment/response in this rule making. There is a comment stating that the exemption to the licensure requirements at N.J.S.A. 45:14B-6 will apply to psychologists in other states who provide services in New Jersey through telemedicine or telehealth. Adopted New Rules: N.J.A.C. 13:42-13.
- On October 19, 2020, at 52 N.J.R. 1925(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee adopted telemedicine regulations for audiologists/speech pathologists. Adopted New Rules: N.J.A.C. 13:44C-11.
- On October 19, 2020, at 52 N.J.R. 1927(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Social Work Examiners adopted telemedicine regulations for social workers. There is a lengthy comment section in this rulemaking. Adopted New Rules: N.J.A.C. 13:44G-15.
Pharmaceutical Price Reduction Approaches
October 28, 2020
Posted by Frank Ciesla
It has now become clear that there are two different approaches being proposed in the Presidential election. President Trump has, through Executive Order, to a limited extent, enacted a Most Favored Nation application to pharmaceuticals. That is a position that I have been advocating for a significant period of time.
Former Vice President Biden is proposing to negotiate rates. Criteria for the rate negotiation process would have to be developed. The criteria would need to be equally applicable to both well-established pharmaceutical companies, as well as start-ups, and will also need bureaucrats to negotiate the rates. The first question is, who will set the criteria. It should be set by Congress, but the question is, how long will that take. Also the question is, will the negotiated rates be applicable only to governmental programs or, like the Most Favored Nation approach, be applied to all drugs sold in the United States whether to governmental programs or to, or through, other programs. The negotiated approach may have a greater level of complexity involved.
I have been advocating for the Most Favored Nation clause long before the Trump presidency since I believe that is the least difficult and most effective approach to reduce pharmaceutical prices.
Most-Favored Nation Update
August 24, 2020
Posted by Frank Ciesla
Over the last couple of years I have been writing blogs suggesting that we adopt a Most-Favored Nation clause in regard to pharmaceuticals.
- Most Favored Nations
- Prescriptions from Outside the US
- Pharmaceuticals
- Pharmaceutical Pricing: Update to May 17, 2018 Blog
- Pharmaceutical Pricing
It appears that President Trump has adopted this concept and has incorporated it in some of his Executive Orders. However, for this concept to be effective and to be a long term solution, Congress needs to adopt it as part of a statute, not just applicable to Medicare or other governmental programs, but applicable to all pharmaceuticals in interstate commerce.
It does not appear that this will occur in this Session of Congress, but hopefully it will be addressed in the next Administration, whether Trump or Biden, as well as the next Congress.
July and August 2020 State Regulatory Developments
August 20, 2020
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in July and August 2020:
- On July 6, 2020, at 52 N.J.R. 1336(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted amendments to existing regulations related to the registration and permit requirements for Graduate Medical Education programs in medicine and podiatry. Many of the changes pertain to foreign medical graduates. See amended N.J.A.C. 13:35-1.5, 3.11, and 3.11A.
Yes, New Jersey, There is Still a Public Health Emergency
July 9, 2020
Posted by Anjali Baxi
On July 2, 2020, Governor Murphy issued Executive Order No. 162 to extend the Public Health Emergency (PHE) that was declared on March 9, 2020 through Executive Order No. 103. Under the Emergency Health Powers Act, a declared public health emergency expires after 30 days unless renewed. The PHE was previously extended on April 7th (EO 119), May 6th (EO 138), and June 4th (EO 151).
One reason cited in Executive Order No. 162 for the extension of the PHE is to ensure that the State can swiftly respond to take all appropriate actions in the event that the rate of reported new cases of COVID-19 in New Jersey, number of individuals being admitted to hospitals for COVID-19, or rate of reproduction for COVID-19 infections in New Jersey increase once more, as we are now seeing in numerous states across the country. Read more
June 2020 State Regulatory Developments
July 1, 2020
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in June 2020:
- On June 1, 2020, at 52 N.J.R. 1150(a), the Department of Health Commissioner issued a notice of rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) related to the qualifications an administrator of an assisted living residence or comprehensive personal care home. This waiver was issued to ensure that a sufficient number of qualified administrators are available to staff New Jersey’s assisted living facilities and comprehensive personal care homes so that the facilities can effectively address the increasing number of both staff and residents being diagnosed with or suspected of having COVID-19. Section 8:36-3.2 has been temporarily amended to permit individuals whose Assisted Living Administration certification had become inactive within the past three years (April 1, 2017-April 1, 2020) to restore their licenses provided that they have not been disqualified, is not under an investigation by the ALA panel or other state licensing authority, does not have a suspended, revoked or restricted certification and no failed a criminal background check. If these bars have been cleared, then the applicant must complete a 10 hour Temporary Living Administrator Program sponsored by Longtree & Associates, LLC; successfully pass a criminal background check pursuant to N.J.A.C. 8:43I-4; and pay the current Assisted Living Administrator certification fee.
This temporary rule waiver/modification, as well as any provisional certifications issued thereunder, will expire 45 days after the end of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103 (2020). After the provisional certifications issued under this subsection have expired, individuals whose Assisted Living Administrator certifications have expired will no longer be permitted to function as certified assisted living administrators. Individuals wishing to obtain full certification as an assisted living administrator will be required to successfully complete all the requirements for restoration of such certifications set forth in this section (excluding the new subsection). Read more
March and April 2020 State Regulatory Developments
May 28, 2020
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in March and April 2020:
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- On March 2, 2020, at 52 N.J.R. 10(a), Department of Law and Public Safety, Division of Consumer Affairs, the Board of Nursing issued a rule proposal to amend N.J.A.C. 13:37 Subchapter 1, relating to nursing programs. The proposed amendments would require nursing program administrators to have three years of experience with a background in developing curriculum; limit the body of graduates that will affect a nursing program’s licensing examination pass rate; delete requirements that faculty members who teach online have a New Jersey license; and require half of the faculty in practical nursing programs to hold master’s degrees. The Board proposes these amendments and new rules in recognition of the ongoing evolution of the role of registered professional nurses and licensed practical nurses with the goal of ensuring that individuals entering the nursing professional receive a high-quality education that equips them to provide nursing services in a safe and effective manner.
May 2020 State Regulatory Developments
May 20, 2020
Posted by Anjali Baxi
On May 18, 2020 at 52 N.J.R. 1083(b), the Department of Health issued a notice of readoption of N.J.A.C. 8:43E, General Licensure Procedures and Standards Applicable to All Licensed Facilities, which was set to expire on May 16, 2020. The Department readopted the rules without amendment, and those rules will continue to be in effect for seven years. In the readoption notice, the Department acknowledged that it is developing rulemaking to revise, update and reorganize the existing N.J.A.C. 8:43E, and anticipates filing the rulemaking in the ordinary course. However, due to the Public Health Emergency that Governor Philip D. Murphy declared in Executive Order No. 103, on March 9, 2020, has necessitated the reallocation of many Department personnel and resources to pandemic response activities, making it unlikely that the Department will be able to finalize the anticipated rulemaking prior to chapter expiration. In addition the declaration has made impracticable the convening of a meeting of the Health Care Administration Board to obtain that Board’s authorization to process the anticipated rulemaking, as required by the Health Care Facilities Planning Act, N.J.S.A. 26:2H-1 et seq. Therefore, the Department will not be able to finalize the anticipated rulemaking prior to the expiration of existing N.J.A.C. 8:43E. The rule was adoption is effective April 13, 2020 until April 13, 2027. Read more
Hospital and Ambulatory Surgery Center Elective Surgery and Invasive Procedure Guidance Issued By Department of Health
May 19, 2020
Posted by Beth Christian
As set forth in Executive Order 145 (issued May 15th, 2020), hospitals and other health care
facilities may resume elective surgeries and invasive procedures on May 26th, 2020.
Guidance for hospital resumption of elective procedures was issued on May 19, 2020 and
can be found here:
https://nj.gov/health/legal/covid19/5-19-2020_HospitalGuidance_forResumingElectives.pdf. Guidelines for ambulatory surgery centers can be found here: https://www.nj.gov/health/legal/covid19/5-19-2020_ASCGuidance_forResumingElectives.pdf.
Resumption of Elective Surgeries in New Jersey Announced
May 15, 2020
Posted by Beth Christian
At the daily Covid-19 briefing held on Friday May 15th, Governor Murphy and Commissioner of Health Persichelli announced that New Jersey health care facilities can resume the provision of elective surgeries on Tuesday, May 26th. Further guidance regarding protocols that will need to be in place should be issued by Monday, May 18th.
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