April 2021 State Regulatory Developments
July 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 April 2021:
- On April 5, 2021 at 53 N.J.R 459(a), the Commissioner of Health modified rule N.J.A.C 8:33E-1.4 and -2.3 pursuant to executive order 103, concerning the minimum volume utilization requirements for invasive cardiac diagnostic facilities, cardiac surgical centers, and physicians practicing at those facilities. Some facilities were unable to meet their volume requirements because of the reduced number of elective procedures as a result of COVID-19. According to this rule:
- The minimum volume utilization requirement for facilities outlined in N.J.A.C 8:33E-1.4 and -2.3 are waived for the duration of the Public Health Emergency, as long as one quarter of the facility’s reporting cycle is covered by the Public Health Emergency; and
- Physician volume utilization requirements are waived for any calendar year that the Public Health Emergency was in effect for 90 days or more.
May 2021 State Regulatory Developments
July 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 May 2021:
- On May 3, 2021, at 53 N.J.R. 677(a), the Department of Banking and Insurance, Small Employer Health Program proposed an amendment regarding small employer health benefit plans. This includes language that should be changed to comply with several Public Laws. See proposed N.J.A.C. 11:21.
- On May 3, 2021, at 53 N.J.R. 680(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy, proposed an amendment that will allow pharmacy interns and externs, under direct supervision of a pharmacist, to administer vaccinations. See proposed N.J.A.C 13:39-4.21.
- On May 3, 2021, at 53 N.J.R. 700(b), the Health Department, Division of Certificate of Need and Licensing, Certificate of Need and Healthcare Facility Licensure Program, adopted several amendments and a new rule addressing hospice licensing standards and patient care services. This includes changes to the language of definitions and new guidelines for acceptance and disposal of prescription medication. See adopted N.J.A.C 8:42C-6.4. See adopted N.J.A.C. 8:42C-1.2, 2.1, 2.5, 2.7, 3.1, 3.2, 3.3, 3.5, 10.2, 10.7, 11.8.
- On May 3, 2021 at 53 N.J.R. 703(a), the Department of Health, Health Systems Branch, Division of Certificate of Need and Licensing, repealed and adopted a new rule, as well as adopted several amendments. Definitional changes, licensure procedure changes, and other requirement changes were made to the Manual of Standards for Licensing of Ambulatory Care Facilities. Several changes were made to the Hospital Licensing Standards. A new form was added for the Acute Stroke Registry, which can be found at http://www.nj.gov/health/forms. See adopted N.J.A.C 8:43G-7A. See adopted N.J.A.C 8:43A-1.3, 2.2 2.3, 2.4, 2.5, 2.8, 2.9, 3.3, 3.4, 3.6, 3.7, 12.7, 16.3, 23.3, 28.3, 28.7, 29.1, 30.7, 30.10, 33.1, 33.4. See adopted N.J.A.C. 8:43G-2.13, 5.16, 7.23, 7.28, 7A.6, 12.12, 15.1, 16.1, 23.6, 28.19, 28.24, 32.23.
- On May 3, 2021, at 53 N.J.R. 717(a), the Department of Human Services, Division of Disability Services, provided an updated Consumer Cost Share Obligation Table for 2021. See adopted N.J.A.C. 10:140-4.3.
- On May 17, 2021, at 53 N.J.R. 761(a), the Governor extended the Public Health Emergency. See Exec. Order No 235.
- On May 17, 2021, at 53 N.J.R. 936(b), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing, adopted new amendments and new rules addressing the Nurse Licensure Compact. See adopted N.J.A.C 13:37-2.1, 2.2, 2.3, 7.1, 9.3. See adopted N.J.A.C 13:37-2.4, 8.4.
- On May 17, 2021, at 53 N.J.R. 937(a), the Department of Law and Public Safety, Divisions of Consumer Affairs, New Jersey Board of Nursing, adopted amendments addressing continuing education and educational requirements for certification of advanced practice nurses. See adopted N.J.A.C 13:37-5.3, 7.2.
- On May 17, 2021, at 53 N.J.R. 953(a), the Department of Health released a public notice cancelling the certificate of need call for more long-term care beds for severe behavior management, which was originally in accordance with N.J.A.C. 8:33-4.1(a) and N.J.S.A. 26:2H-1.
Special thanks to Jessica Warwick, Summer Associate
February 2021-March 2021 State Regulatory Report
March 16, 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 February and March 2021:
- On February 16, 2021 at 53 N.J.R. 195(a), the Commissioner of Health adopted a temporary rule waiver/modification of the requirements governing the expiration and renewal of certificates for Certified Medication Aides (CMAs) at N.J.A.C. 8:36-9.2. Section 6 of EO 103 that modifies the expiration dates and recertification requirements for CMAs as follows:
- CMA certifications that expire between March 1, 2020 and December 31, 2020, are automatically extended until March 19, 2021; and
- Any CMA whose certification expires between March 1, 2020 and December 31, 2020, are permitted to renew his or her certification outside of the two-year renewal window, up to and including March 19, 2021; and
- CMAs with certifications expiring between March 1, 2020 and December 31, 2020, are permitted to complete CEUs required for recertification up to March 19, 2021.
After March 19, 2021, all CMAs will be required to comply with all regular recertification requirements set forth in N.J.A.C. 8:36-9.2 (b) and (d).
- On February 16, 2021 at 53 N.J.R. 273(a), the Department of Health, in compliance with N.J.S.A. 52:14-34.4 et seq. (P.L. 1987, c. 7), the Department of Health published notice of grant availability, subject to fund availability, in the Department of Health Directory of Grant Programs. This publication may be viewed through the Internet at: http://healthapps.state.nj.us/noticeofgrant/noticegrants.aspx.
- On March 1, 2021, at 53 N.J.R. 366(a) the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted amendments to rules that permit all licensed midwives to administer, or facilitate the administration of, nitrous oxide for pain relief in health care facilities licensed by the Department of Health. See N.J.A.C. 13:35-2A.10 and 2A.12.
- On March 15, 2021, at 53 N.J.R. 406(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C. 13:30-9.
- On March 15, 2021, at 53 N.J.R. 410(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Alcohol and Drug Counselor Committee, proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C. 13:34C-7.
- On March 15, 2021, at 53 N.J.R. 414(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Respiratory Care, proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C. 13:44F-11
- On March 15, 2021, at 53 N.J.R. 417(a), the Department of Law and Public Safety, Division of Consumer Affairs, Occupation Therapy Advisory Council, proposed a new subchapter addressing telemedicine and telehealth regulations. See proposed N.J.A.C N.J.A.C. 13:44K-7.
- On March 15, 2021, at 53 N.J.R. 427(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Veterinary Medical Examiners adopted new telemedicine and telehealth regulations. The commentary discusses at length that, veterinarians are healthcare providers that provide health care services to animals and are subject to the telemedicine statute. See N.J.A.C. 13:44-4A.
- On March 15, 2021, at 53 N.J.R. 435(a), the Department of Health published a notice postponing the certificate of need call for applications for new specialized long-term beds for pediatric care in accordance with the provisions of N.J.A.C. 8:33H-1.5 and N.J.S.A. 26:2H-1 et seq.
- On March 15, 2021, at 53 N.J.R. 435(b), the Department of Health published a notice postponing certificate of need call for applications for new specialized long-term beds for severe behavior management in accordance with the provisions of N.J.A.C. 8:33H-1.6 and N.J.S.A. 26:2H-1 et seq.
- On March 15, 2021, at 53 N.J.R. 435(c), the Department of Health published a notice postponing the certificate of need call for applications for new specialized long-term beds for ventilator care in accordance with the provisions of N.J.A.C. 8:33H-1.6 and N.J.S.A. 26:2H-1 et seq.
New Policy to Remove Barriers to COVID-19 Testing
March 3, 2021 | No Comments
Posted by Anjali Baxi
On February 26, 2021, the Centers for Medicare & Medicaid Services, Department of Labor and Department of Treasury issued guidance removing barriers to COVID-19 diagnostic testing and vaccinations and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. This guidance makes clear that private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health coverage who are asymptomatic, and who have no known or suspected exposure to COVID-19. Such testing must be covered without cost sharing, prior authorization, or other medical management requirements imposed by the plan or issuer. For example, covered individuals wanting to ensure they are COVID-19 negative prior to visiting a family member would be able to be tested without paying cost sharing. The guidance also includes information for providers on how to get reimbursed for COVID-19 diagnostic testing or for administering the COVID-19 vaccine to those who are uninsured. Click here for the newly issued guidance. See press release here.
The new guidance should encourage providers to offer COVID-19 testing at their offices and outpatient locations since private group health plans and issuers must cover and reimburse for COVID-19 testing of asymptomatic individuals and defers to the provider’s individual clinical assessment of the patient to determine whether the patient should be tested for COVID-19. This new guidance should also increase patient access to testing and remove barriers to encourage patients to be tested prior to travel without fears of large out of pocket payment for testing. The provider should check with health plans to confirm that they have implemented this policy prior to starting to administer the test to the newly covered group. Likewise, patients should check their coverage under their health plans.
December 2020/January 2021 State Regulatory Report
March 3, 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 December 2020 and January 2021:
- On December 7, 2020, at 52 N.J.R. 2144(a), the Department of Health published a public notice postponing certificate of need call for applications for additional pediatric intensive care beds in accordance with the provisions of N.J.A.C. 8:33 and N.J.S.A. 26:2H-1 et seq., scheduled for September 1, 2020, until September 1, 2021.
- On January 4, 2021, at 53 N.J.R. 12(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, proposed to repeal N.J.A.C. 13:35-4.2 (Rule 4.2), which regulates abortions, and to amend N.J.A.C. 13:35-4A (Rule 4A) to remove barriers to abortion care that are unrelated to safety and to ensure abortions are regulated like other office-based surgical and special procedures. This includes proposing advanced practice clinicians (APCs)-namely, advanced practice nurses (APNs), physician assistants (PAs), certified nurse midwives (CNMs), and certified midwives (CMs)-be permitted to perform certain abortions. Proposed Amendments: J.A.C. 13:35-4A.1 through 4A.12; Proposed New Rule: N.J.A.C. 13:35-4A.19; Proposed Repeal: N.J.A.C. 13:35-4.2. Comments Due: March 5, 2021.
- On January 4, 2021, at 53 N.J.R. 81(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Psychological Examiners adopted an amendment to N.J.A.C. 13:42-2.4 regarding degrees earned outside of the United States. It requires individuals who apply for licensure to provide the Board with comprehensive evaluation of their degree performed by the National Register of Health Service Psychologists or a foreign credential evaluation service that is member of the National Association of Credential Evaluation Services (NACES). See N.J.A.C. 13:42-2.4.
- On January 4, 2021, at 53 N.J.R. 86(a), the Department of Health published the anticipated schedule for receipt of certificate of need applications subject to full review procedures for the period beginning January 1, 2021.
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Deadline for Submission | |
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1/2/21 | and annually thereafter |
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1/2/21 | and annually thereafter |
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1/2/21 | and annually thereafter |
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1/2/21 | and annually thereafter |
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9/1/21 | and annually thereafter |
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2/1/21 | and every two years thereafter |
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3/1/21 | and every two years thereafter |
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4/1/22 | and every three years thereafter |
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4/1/22 | and every three years thereafter |
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6/1/22 | and every three years thereafter |
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6/1/22 | and every three years thereafter |
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7/1/22 | and every three years thereafter |
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7/1/22 | and every three years thereafter |
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4/1/21 | and every five years thereafter |
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4/1/21 | and every five years thereafter |
- On January 19, 2021, at 53 N.J.R. 101(a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of the requirements governing the expiration and renewal of certifications for Certified Nurse Aides (CNAs) under N.J.A.C. 8:39-43.4 and N.J.A.C. 8:39-43.6. Pursuant to this temporary rule waiver/modification, the expiration date of any nurse aide certification scheduled to expire between March 1, 2020 and December 31, 2020 shall be extended until March 19, 2021. Additionally, any certified nurse aide whose certification is scheduled to expire between March 1, 2020 and December 31, 2020 shall be permitted to renew his or certification outside of the two-year renewal window, up to and until March 19, 2021. After March 19, 2021, all CNAs will be required to resume complying with all regular certification requirements set forth in N.J.A.C. 8:39-43.4 and N.J.A.C. 8:39-43.6. Effective September 1, 2020 to March 19, 2021.
- On January 19, 2021, at 53 N.J.R. 101(b), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of the requirement that ambulatory care facilities with licensed mobile vans submit to the Department a service schedule, which includes, but is not limited to, dates, times and address(es) where the licensed mobile van will be temporarily stationed to provide licensed care, or memorandums of understanding between a licensed mobile van and host location. Ambulatory care facilities operating mobile vans may implement the terms of this waiver as necessary until the conclusion of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103. See N.J.A.C. 8:43A-23.3 (c).
- On January 19, 2021, at 53 N.J.R. 102 (a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of N.J.A.C. 8:43I-2.9(c), which sets the criminal background clearance requirements for individuals seeking certification or recertification as a nurse aide. The Department, through this rule modification, is providing an additional extension of the expiration date of criminal background clearance notifications issued to CNAs and CNA candidates to ensure that there is adequate staffing of CNAs in good-standing at long term care facilities throughout the State. Accordingly, the Department is extending the expiration dates of criminal background clearance notifications issued to CNAs and CNA candidates between November 1, 2019 and June 30, 2020 until March 19, 2021. If full certification is not obtained by March 19, 2021, the notice shall expire, and a new criminal history report must be obtained. See N.J.A.C. 8:43I-2.9
- On January 19, 2021, at 53 N.J.R. 107(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Dentistry proposed an amendment to N.J.A.C. 13:30-8.18 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:30-8.18 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment N.J.A.C. 13:30-8.18.
- On January 19, 2021, at 53 N.J.R. 109(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Nursing proposed to amend N.J.A.C. 13:37-7.9A to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:37-7.9A to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. These limitations and requirements apply to certified advanced practice nurses. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment: N.J.A.C. 13:37-7.9A
- On January 19, 2021, at 53 N.J.R. 112(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Optometrists proposed to amend N.J.A.C. 13:38-2.5 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:38-2.5 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on the prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarify the timing of the requirement to enter into a pain management agreement, amend the definition of “initial prescription,” and revise the definition of “chronic pain” consistent with the amended statute. Proposed Amendment: N.J.A.C. 13:38-2.5
- On January 19, 2021, at 53 N.J.R. 114(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy proposes to readopt N.J.A.C. 13:39A with amendments, repeals, and new rules. Proposed Readoption with Amendments: N.J.A.C. 13:39A; Proposed Repeals and New Rules: N.J.A.C. 13:39A-5.5 and 5A; Proposed New Rules: N.J.A.C. 13:39A-4.3 and 5.2A.
- On January 19, 2021, at 53 N.J.R. 124(c), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted the amended rule requiring physicians to co-prescribe an opioid antidote under certain circumstances. Adopted Amendment: N.J.A.C. 13:35-7.6.
- On January 19, 2021, at 53 N.J.R 137(a), the Department of Health published a public notice of petition for rulemaking for rule changes that permit the establishment of elective PCTA services with off-site cardiac surgery backup to be reviewed under the expedited CN review process and established rules for submission of CN applications for the provision of elective PCI at hospitals with off-site cardiac surgery back up. See N.J.A.C. 8:33E-2.17.
Saga of “Most Favored Nations”
December 29, 2020 | No Comments
Posted by Frank Ciesla
On Wednesday, December 23, 2020, a Maryland Federal District Court Judge issued a TRO blocking the Trump administration’s attempt to institute, pursuant to an administrative rule, a Most Favored Nations approach for dozens of drugs under the Medicare Program.
The challenge made to the administrative rule was that it was issued under the “emergency” provisions of the Administrative Procedure Act. The Plaintiffs argued that the Federal government did not present adequate justification for the use of that provision for the adoption of an administrative rule, rather than use the normal avenue requiring public comment prior to the adoption of the rule.
It is highly unlikely that this issue will be resolved during the remaining couple of weeks of the Trump administration. Therefore, it will be up to the Biden administration as to whether or not they want to (i) continue the litigation to justify the rule, (ii) take the approach of readopting the rule pursuant to the provision for public review and comment prior to the adoption of the rule, or (iii) abandon the entire Most Favored Nations approach to pricing of pharmaceuticals in the United States altogether. What is clear, is that the rule will not be implemented during the remaining couple of weeks of the Trump administration.
As can be seen by our prior blogs we have been an advocate for the “Most Favored Nations” approach for a number of years.
Pharmaceutical Industry Challenges President Trump’s Executive Order Adopting Most Favored Nation Approach
December 8, 2020 | No Comments
Posted by Frank Ciesla
My December 2, 2020 blog was a discussion of President Trump’s adoption of the Most Favored Nation approach for the pricing of certain drugs in various federal programs. On Friday, the pharmaceutical industry filed suit challenging the decision of the Trump Administration. It will be interesting to see what action, if any, the new President takes to defend the concept or whether the incoming President will walk away from the concept of Most Favored Nation.
President Trump issues Executive Order adopting Most Favored Nation Approach
December 2, 2020 | No Comments
Posted by Frank Ciesla
In what appears to be one of President Trump’s last official acts, he has issued an Executive Order adopting, for certain purposes, the Most Favored Nation clause approach to the pricing of drugs in the United States. During the campaign, it was the position of President-Elect Biden that we should be negotiating the price with the drug companies for the sale of drugs in the United States.
Obviously, an Executive Order by one President can be quickly replaced with an Executive Order by the next President.
The only approach in regard to institutionalizing the Most Favored Nation clause approach to drug pricing, would be Congressional legislation, which has not been forthcoming during the four years of the Trump Administration.
A recent development is the decision of the Canadian government to enact significant restrictions on the bulk purchase of drugs in Canada for shipment into the United States. This is most likely the result of pressure by the drug companies, who have made it clear to the Canadians that the drug companies will only provide Canada with a certain quantity of drug products at particular pricing levels and at quantities which are sufficient for the Canadian population alone. The drug companies will not permit the Canadians to sell drugs that had been purchased at the much cheaper Canadian price than the price for which those drugs are sold in the United States to institutions in the United States.
This action of the Canadians highlights that the approach of the Most Favored Nation clause would not be greeted in a friendly manner, by many of our allies. These allies benefit from being able to negotiate cheaper prices for drugs, since the drug companies can then make up the shortfall needed for their R&D or their profit, by charging much higher prices for drugs in the United States. Enacting a Most Favored Nation clause would shut down that option, on behalf of the drug companies, and they would be forced to negotiate with our allies at much higher prices for drugs sold to the allies. Of course, this would stop the cost shifting to the American consumers and spread the cost of the development of drugs among all users, including those of our allies.
It will be interesting to see what approach the Biden Administration takes in regard to the pricing of drugs and whether or not it will continue the Trump approach of Most Favored Nation or will attempt to develop a different negotiating strategy for the pricing of drugs.
November 2020 State Regulatory Developments
November 23, 2020 | No Comments
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in November 2020:
- On November 2, 2020, at 52 N.J.R. 1990(a), Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners issued a rule proposal to amend N.J.A.C. 13:42-8.1 to require that a licensee retain records for a minor for seven years from the date of the last entry or until the client turns 25 years of age, whichever is longer.
- On November 2, 2020, at 52 N.J.R. 2008(c), Department of Labor published a notice of administrative change regarding the minimum wage rates as they progress to the $15 minimum wage over For most employees, the rate as of January 1, 2021 is $11.00. There are exceptions for certain employers, i.e., small employers/seasonal workers. N.J.A.C. 12:56-3.1, 3.2, and 3.3.
- On November 2, 2020, at 52 N.J.R. 2010(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee adopted an amendment prohibiting hand-written continuing educations credit certificates. Adopted Amendment: N.J.A.C. 13:44C-6.3.
- On November 16, 2020, at 52 N.J.R. 2038(a), the Department of Health issued notice of emergency adoption of a rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) waiving the continuing education requirements for active health officer and registered environmental health specialist (REHS) licenses set out at N.J.A.C. 8:7-1.11, N.J.A.C. 8:7-1.12, N.J.A.C. 8:7-1.13, and N.J.A.C. 8:7-1.17. Under current rules, active licensed health officers or REHSs who wish to renew their licenses in their respective public health positions must annually obtain 15 contact hours of approved continuing education (CE) and submit verification of the CEs with their annual license renewal application. Due to the pressing demands caused by this public health emergency, it is both necessary and appropriate to temporarily relax these requirements for current active health officers and REHSs who are renewing their licenses as active for the 2021 licensing period by waiving the CE requirement. This waiver will not only provide active licensed health officers and REHSs a reprieve from this obligation so they may focus on the public response to COVID-19 in New Jersey but will also ensure that the State maintains a sufficient number of active licensed health officers and REHSs to carry out essential public health services and respond to the public health emergency.
September and October 2020 State Regulatory Developments
November 20, 2020 | No Comments
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.
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