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December 4, 2017 Regulatory Developments

December 5, 2017 | No Comments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on December 4, 2017:

  • On December 4, 2017 at 49 NJR 3728, the Department of Health published notice of its readoption with amendments to its rules governing its management and governing body standards with the amendments incorporate the transfer of mental health and addiction functions from the Department of Human Services to the Department of Health.
  • On December 4, 2017 at 49 NJR 3754, the Department of Banking and Insurance published notice of its adoption of amendments to its rules governing minimum reserve standards for individual and group health insurance contracts.
  • On December 4, 2017 at 49 NJR 3755, the Department of Banking and Insurance published notice of its adoption of amendments to its rules governing eligibility for individual health insurance coverage.
  • On December 4, 2017 at 49 NJR 3757, the Department of Banking and Insurance published notice of its adoption of amendments to its rules governing eligibility for coverage under the small employer health benefits program.
  • On December 4, 2017 at 49 NJR 3761, the Board of Pharmacy published notice of its readoption with amendments to its rules and the adoption of new rules governing the practice of pharmacy.
  • On December 4, 2017 at 49 NJR 3779, the State Board of Psychological Examiners published notice of its adoption of amendments to its rules which will allow licensure without a psychologist having to take an examination under certain circumstances.

 

 

November 6, 2017 Regulatory Developments

November 29, 2017 | No Comments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on November 6, 2017:

  • On November 6, 2017 at 49 NJR 3481, the State Board of Medical Examiners published notice of its proposal of amendments to its rules regarding the delegation of the administration of subcutaneous and intramuscular injections and performance of venipuncture to certified medical assistants. The proposal would amend existing regulations regarding education for certified medical assistants to reduce required clock hours from 600 to 330.  The proposed amendments would also amend the definition of the term “certified medical assistant” to recognize new entities that train certified medical assistants and would permit certified medical assistants to perform venipuncture as long as they have completed the requisite education and training.
  • On November 6, 2017 at 49 NJR 3545, the State Board of Dentistry published notice of its readoption of its rules governing the practice of dentistry.
  • On November 6, 2017 at 49 NJR 3549, the State Board of Dentistry published notice of its denial of a petition for rulemaking filed by the American Board of Dental Specialties. The petition had sought to have the Board of Dentistry formally recognize the ABDS-recognized certifying boards/areas of practice for specialist designation.  In denying the petition, the Board indicated that while it agrees that its existing specialty advertising rules should be amended, it needed more time to consider comments to a preproposal that it had published concerning specialty advertising.

 

 

 

 

NJ Department of Health Awards Psychiatric Beds

November 22, 2017 | No Comments
Posted by Anjali Baxi

After months of being focused on the certificate of need call for inpatient adult psychiatric beds, the Department of Health (DOH) has announced the list of approved applicants.  As part of his commitment to provide more behavioral health services, Governor Christie sought to expand New Jersey’s adult acute care psychiatric bed capacity by over 800 beds, a 40% increase in the total adult acute care beds available in New Jersey.  This is the largest expansion in 20 years. The DOH expects to issue another CN call for 53 psych beds in Hunterdon, Warren and Morris Counties. Read more

October 16, 2017 Regulatory Developments

October 20, 2017 | No Comments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on October 16, 2017:

  • On October 16, 2017 at 49 N.J.R. 3419, the Department of Labor and Workforce Development published notice of its proposal of a new rule governing electronic claims submissions. The new rule will require all worker’s compensation claims for reimbursement by health care providers to be submitted electronically.
  • On October 16, 2017 at 49 N.J.R. 3435, the Department of Human Services published notice of its adoption of a new rule governing the implementation of a new medical necessity review tool for substance abuse disorders.

October 2, 2017 Regulatory Developments

October 18, 2017 | No Comments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on October 2, 2017:

  • On October 2, 2017 at 49 N.J.R. 3294, the Department of Human Services published notice of its proposed readoption with amendments to the rules governing hospital services under Medicaid.
  • On October 2, 2017 at 49 N.J.R. 3324, the Department of Banking and Insurance published notice of its proposal of amendments to its rules governing triggering events for individuals to participate in small employer health benefit plans.
  • On October 2, 2017 at 49 N.J.R. 3329, the Alcohol and Drug Counselor Committee of the Board of Marriage and Family Therapy Examiners published notice of its proposed amendments to its rules governing continuing education. The proposed amendments would require licensees and certificate holders to complete at least three required contact hours of a committee approved continuing education course in legal standards relating to the practice of alcohol and drug counseling in New Jersey.
  • On October 2, 2017 at 49 N.J.R. 3330, the Board of Medical Examiners has proposed new rules concerning limitations on, and obligations associated with, the acceptance of compensation from pharmaceutical manufacturers by prescribers. Among other things, the proposed new rules would establish a $10,000 cap on the dollar amount that a prescriber can accept from pharmaceutical and device manufacturers in a calendar year for bona fide services; would cap the value of meals which can be provided to prescribers at $15.00 per meal; and would preclude prescribers from accepting anything of value (including pens, mugs or other items with a company logo).
  • On October 2, 2017 at 49 N.J.R. 3359, the Department of Health published notice of its readoption of the regulations governing the birth defects registry.
  • On October 2, 2017 at 49 N.J.R. 3360, the Board of Medical Examiners published notice of its adoption of amendments to its rules regarding the standards for the declaration of brain death and the pronouncement of death.
  • On October 2, 2017 at 49 N.J.R. 3367, the Department of Health published notice of a certificate of need call for new pediatric intensive care beds in Morris, Essex, Middlesex, Monmouth and Passaic Counties.
  • On October 2, 2017 at 49 N.J.R. 3367, the Department of Health published notice of its cancellation of the certificate of need call for burn center programs or units.

 

 

September 18, 2017 Regulatory Developments

September 25, 2017 | No Comments
Posted by Beth Christian

 

Here are the most recent health care related regulatory developments as published in the New Jersey Register on September 18, 2017:

  • On September 18, 2017 at 49 NJR 3093, the Department of Banking and Insurance published notice of its proposed amendments to the regulations governing the Individual Health Coverage Program. The proposed regulations will amend certain definitions and will amend coverage to allow for telemedicine visits.
  • On September 18, 2017 at 49 NJR 3096, the State Board of Nursing published proposed amendments to its rules regarding continuing education, as well as the fee schedule for certified sexual assault forensic nurses.
  • On September 18, 2017 at 49 NJR 3097, the Audiology and Speech-Language Pathology Advisory Committee published notice of its proposed amendments to its rules regarding licensure. The proposed rules would modify the requirements for clinical internships.
  • On September 18, 2017 at 49 NJR 3166, the Department of Health published notice of its adoption of amendments to its rules, as well as the adoption of new rules, governing human trafficking handling and response training. The new rules will require healthcare facilities to provide training regarding human trafficking handling and response for all workers who have direct contact and/or interaction with facility patients and/or visitors.
  • On September 18, 2017 at 49 NJR 3168, the Department of Health published notice of its adoption of amendments to its rules regarding childhood elevated blood levels.
  • On September 18, 2017 at 49 NJR 3219, the Department of Health published notice of its adoption of amendments to its rules regarding screening of children for elevated lead blood levels.
  • On September 18, 2017 at 49 NJR 3226, the Department of Human Services published notice of its re-adoption with amendments to its rules governing the Hearing Aid Assistance to the Aged and Disabled Program.
  • On September 18, 2017 at 49 NJR 3232, the Department of Banking and Insurance published notice of its re-adoption of the rules governing medical malpractice liability insurance.

 

 

 

September 5, 2017 Regulatory Developments

September 14, 2017 | No Comments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on September 5, 2017:

  • On September 5, 2017 at 49 N.J.R. 2876, the Department of Banking & Insurance published notice of its proposal of amendments to its rules to clarify impermissible practices relating to health benefits plan claim processing.  The proposed amendments also set forth requirements for the timing of authorization of services and payment of claims after an independent utilization review organization determination adverse to the carrier or health maintenance organization.  The proposed amendments would require payment of the claim no later than 10 business days from receipt of the IURO determination.
  • On September 5, 2017 at 49 N.J.R. 2877, the Department of Banking & Insurance published notice of its proposal of amendments to its rules governing the prompt payment of health benefit claims.  The proposed amendments would set forth minimum requirements for explanation of benefits forms.
  • On September 5, 2017 at 49 N.J.R. 2880, the Department of Banking & Insurance published notice of its proposal of amendments to its rules regarding out of network benefits.  The Department is proposing amendments to its rules to reinforce the existing rights of a covered person to request the opportunity to receive services from an out of network provider, and pay only network level cost sharing, where the network associated with the covered person’s health plan does not have a qualified, accessible and available provider to perform the needed service.
  • On September 5, 2017 at 49 N.J.R. 2895, the State Board of Medical Examiners published notice of its proposal of amendments to its rules governing prescriptions.  Current rules prohibit physicians from dispensing more than a 7 day supply of drugs or medications.  The proposed amendments will implement a statutory change which added an exemption from the 7 day limitation for dispensing a food concentrate, food extract, vitamin, mineral, herb, enzyme, amino acid, tissue or cell solid, glandular extract from a nutraceutical, botanical, homeopathic remedy, or other nutritional supplement.
  • On September 5, 2017 at 49 N.J.R. 2895, the State Board of Nursing published notice of its proposal of amendments to its rules regarding completion of continuing education courses and continuing education requirements for advanced practice nurses.

 

August 21, 2017 Regulatory Developments

August 21, 2017 | No Comments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on August 21, 2017:

  • On August 21, 2017 at 49 N.J.R. 2599, the Department of Children and Families and the Department of Health published notice of their proposal of amendments to their rules regarding substance affected infants.  The Department of Children and Families is proposing a new rule which will specify the content and process by which hospitals and birthing centers must make reports to the Division of Child Protection Permanency in connection with the birth of infants whose mother had a positive toxicology screen for a controlled substance or metabolite during pregnancy or at the time of delivery; who have a positive toxicology screen for a controlled substance after birth that is reasonably attributable to maternal substance use during pregnancy; who displayed effects of prenatal controlled substance exposure or symptoms of withdrawal relating from prenatal controlled substance exposure; or who display the effects of fetal alcohol spectrum disorder.  The Department of Health is proposing supportive amendments which will require that hospitals and birth centers implement policies requiring reports of substance abuse affected infants be made in accordance with the regulations of the Department of Children and Families.
  • On August 21, 2017 at 49 N.J.R. 2675, the Department of Human Services published notice of its proposed amendments to its rules regarding screening and screening outreach programs.  The proposed amendments reflect the inclusion of commitment to outpatient treatment in the commitment law, and delineate the standards and procedures for determining whether a consumer in need of involuntary commitment should be assigned to outpatient or inpatient treatment.
  • On August 21, 2017 at 49 N.J.R. 2698, the Department of Human Services published notice of its proposal of amendments to its rules and the proposal of new rules governing home and community-based services under Medicaid.
  • On August 21, 2017 at 49 N.J.R. 2726, the Department of Banking and Insurance published notice of its proposal of new rules which will set forth various requirements for contracts between pharmacy benefits managers and contracted pharmacies.
  • On August 21, 2017 at 49 N.J.R. 2729, the Department of Banking and Insurance published notice of its proposal of amendments to its rule and the proposal of new rules regarding claims processing.  Among other things, the proposed amendments would add a new provision which would prohibit carriers from denying or delaying payment of a claim while seeking coordination of benefits information, except for good cause.
  • On August 21, 2017 at 49 N.J.R. 2738, the Physician Assistant Advisory Committee of the State Board of Medical Examiners published notice of proposal of amendments to its rules and the proposal of new rules.  The proposed new rules will implement statutory amendments approved in 2015 which expanded physician-delegated scope of practice for physician assistants.  Among other things, the amendments would implement statutory revisions to the scope of practice for physician assistants, implement the requirement that all physician assistants maintain professional liability insurance or a letter of credit, and require physician assistants to have a separate written agreement with each physician who delegates medical services to the physician assistant.
  • On August 21, 2017 at 49 N.J.R. 2746, the State Board of Medical Examiners and the Board of Pharmacy jointly published notice of proposed amendments to their rules and the proposal of a new rule governing procedures for physician-ordered immunizations performed by a licensed pharmacist, as well as the requirements for pharmacists to administer flu vaccines to patients under 18 years of age.
  • On August 21, 2017 at 49 N.J.R. 2750, the State Board of Social Work Examiners published notice of its proposed amendments to its rule and the proposal of new rules governing practice as an LCSW, practice as an LSW and practice as a CSW.  In addition to setting forth scope of practice requirements, the proposal also includes expanded requirements regarding financial arrangements with clients, as well as other provisions concerning sexual misconduct; harassment; discrimination; reporting of violations by other licensees; advertising; the use of professional credentials and certifications; confidentiality; and clinical supervision requirements.
  • On August 21, 2017 at 49 N.J.R 2759, the Division of Consumer Affairs published notice of its amendments to its rules, as well as the amendments of new rules, to provide a definition for the term “companion services” and amend the definition of “health care service firm” to clarify that companion services are only to be offered by registered health care service firms.  The proposal also sets forth accreditation requirements for health care service firms.
  • On August 21, 2017 at 49 N.J.R. 2796, the Department of Health published notice of its readoption of rules governing the standards for attendance and participation at school by persons with HIV infection; standards for the AIDS drug distribution program; standards for HIV/AIDS counseling and testing of pregnant women; and standards for disclosure of children with HIV/AIDS status.
  • On August 21, 2017 at 49 N.J.R. 2800, the Department of Corrections published notice of its readoption with amendments to its rules governing health care services provided in correctional institutions.
  • On August 21, 2017 at 49 N.J.R. 2804, the Department of Banking and Insurance published notice of its adoption of an amendment to its rules regarding life/health/annuity forms.  The amendment incorporates a new definition of stop loss or excess risk insurance.

State Legislative Developments August 2017

August 15, 2017 | No Comments
Posted by Anjali Baxi

On June 26, 2017, Governor Christie signed three pieces of legislation affecting the elderly, organ donation and hospital interns that have been adopted this month.

Governor Chris Christie signed legislation aimed to protect against elder abuse in institutional settings, such as a skilled nursing or assisted living facility.  Coined as “Peggy’ Law,” the legislation requires staff employed by a facility serving elderly persons to report suspected abuse or exploitation of an elderly institutionalized person to the Ombudsman or to the Ombudsman’s designee.  If the facility’s staff person has reasonable cause to believe the elderly institutionalized person has been a victim of a crime, the individual must report the information to the local law enforcement agency and to the health administrator of the facility.  Peggy’s Law requires the Ombudsman’s Office to implement a system to receive complaints on a 24/7 basis.   The legislation amends N.J.S.A. 52:27G 7 and N.J.S.A.52:27G 7.1.

He also signed legislation to amend the Health Care Quality Act to require health insurance carriers, such as the State Health Benefits Program and the School Employees’ Health Benefits Program to inform covered persons about organ and tissue donation.  This will go into effect in September 2017 and amends N.J.S.A. 26:2S-1. et. seq.

In addition, he signed legislation to eliminate the current exemption from unemployment insurance (UI) coverage for service performed as an intern in the employ of a hospital by an individual who has completed a four-year course in a medical school approved pursuant to the laws of this State. The bill therefore provides that those interns would be eligible for UI benefits and subject to UI taxes to the same degree as other hospital employees.  This legislation amends N.J.S.A. 43:21-19.

New Legislation Expands the Scope of Telemedicine in New Jersey

August 10, 2017 | No Comments
Posted by Beth Christian

In July of 2017, Governor Christie signed legislation that will expand the scope of telemedicine practice in New Jersey.[1]  Some of the highlights of the legislation include the following:

  • The law provides that unless specifically prohibited or limited by federal or state law, a health care provider who establishes a proper provider-patient relationship may remotely provide health care services to a patient through the use of telemedicine and may also engage in telehealth as may be necessary to support or facilitate the provision of health care services.
  • The term “telemedicine” is defined as the delivery of a health care service using electronic communications, information technology, or other electronic or technological means to bridge the gap between a health care provider who is located at a distant site and a patient that is located at an originating site, either with or without the assistance of an intervening health care provider.
  • The term “telemedicine” does not include the use, in isolation, of audio-only telephone conversations, email, instant messaging, phone text or fax transmission.
  • The term “telehealth” is defined as the use of information and communications technologies, including phones, remote patient monitoring devices, or other electronic means, to support clinical health care, provider consultation, patient and professional health-related education, public health, health administration and other services.
  • The law covers numerous categories of health care providers, an individual who provides health care service including, but is not limited to, physicians, nurses, nurse practitioners, psychologists, psychiatrists, psychoanalysts, clinical social workers, physician assistants, professional counselors, respiratory therapists, speech pathologists, audiologists, optometrists, or any other health care professional acting within the scope of a valid license or certification pursuant to Title 45 of the Revised Statutes.
  • Health care providers who use telemedicine or engage in telehealth must be: (1) validly licensed, certified or registered to practice in the State of New Jersey; (2) remain subject to regulation by the appropriate New Jersey state licensing board or other New Jersey professional regulatory entity; (3) act in compliance with existing requirements regarding the maintenance of liability insurance for their practice area; and (4) remain subject to New Jersey jurisdiction if either the patient or the provider is located in New Jersey at the time that the services are provided.
  • Health care providers engaging in telemedicine and telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of images, diagnostics, data and medical information. Health care providers may use interactive real-time two-way audio in combination with asynchronous store-and-forward technology, without video capabilities, if, after accessing and reviewing the patient’s medical records, the provider determines that they are able to meet the same standard of care as if the health care services were being provided in person.
  • The term “asynchronous store-and-forward” means the acquisition and transmission of images, diagnostics, data, and medical information either to, or from, an originating site or to, or from the healthcare provider at a distant site which allows the patient to be evaluated without being physically present.
  • Any health care provider who provides health care services using telemedicine or telehealth will be held to the same standard of care or practice standards applicable to in-person settings. Persons should be directed to seek in-person care if telemedicine or telehealth services would not be consistent with the standard of care.
  • The legislation directs each of the state professional boards to (as well as other entities that regulate health care providers) to adopt rules and regulations that are necessary to implement the provisions of the telemedicine law and facilitate the provision of telemedicine and telehealth services.
  • The regulations referenced above are required to include best practices for professional engagement in telemedicine and telehealth. In addition, they must ensure that the services patients receive using telemedicine or telehealth are appropriate, medically necessary and meet current quality of care standards and include measures to prevent fraud and abuse.  The regulations also must provide substantially similar metrics for evaluating quality of care and patient outcomes in connection with telemedicine and telehealth services as currently applied to services provided in person.
  • The legislation also provides that “in no case shall the rules and regulations adopted by the professional boards or other licensing entities require a provider to conduct an initial in-person visit with the patient as a condition of providing services using telemedicine or telehealth.” This was one of the prior impediments to practitioners utilizing telemedicine services, as an in-person visit was previously required in many instances.
  • In addition, the statute expressly provides that the failure of any licensing board to adopt rules and regulations regarding telemedicine and telehealth will not delay the implementation of the telemedicine statute, and cannot prevent health care providers engaging in telemedicine or telehealth in accordance with the law and the practice act applicable to the provider’s professional licensure, certification and registration. The legislation also includes standards for the establishment of a proper provider- patient relationship, as well as cross-coverage obligations.
  • Telemedicine or telehealth organizations operating in the state are required to annually register with the Department of Health and meet certain reporting requirements.
  • The legislation also establishes the Telemedicine and Telehealth Review Commission in the Department of Health.
  • Finally, the legislation requires coverage of telemedicine and telehealth services by third party payors (including government payors).

For further information about the new law applicable to the provision of health care services through telemedicine and telehealth, please contact Beth Christian, Frank Ciesla or Anjali Baxi of Giordano, Halleran & Ciesla’s health care practice area.

 

[1] N.J.S.A. 45:1-61-66 (general); N.J.S.A. 30:4D-6k (Medicaid/NJ Fam Care coverage); N.J.S.A. 26:2S-29 (private coverage); N.J.S.A. 52:14-17.29 (SHBP coverage); N.J.S.A. 52:14-17.46.6h (SEHBP/SHBP coverage).

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