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Health Law Section Report – January and February 2020

March 13, 2020
Posted by Anjali Baxi

Here are the most recent health care related regulatory developments as published in the New Jersey Register in January and February 2020:

  • On January 6, 2020, at 52 N.J.R. 10(a), 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.
  • On January 6, 2020, at 52 N.J.R. 16(a), the Board of Nursing issued a proposed new rule to permit nursing education programs to require students to take a predictor examination at the end of the program, but to also prohibit a program from preventing a student from graduating or taking a licensing examination, based on the student’s performance on the predictor examination.
  • On January 6, 2020, at 52 N.J.R. 45(a), the Board of Nursing adopted a final rule amending the rules related to provisional accreditation of nursing programs. See N.J.A.C. 13:37-1.3.
  • On February 3, 2020, at 52 N.J.R. 143(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted new telemedicine regulations related to Hearing Aid Dispensers that are consistent with telemedicine regulations adopted by other licensing boards. The new regulations are at N.J.A.C. 13:35-8.21-8.28.
  • On February 18, 2020, at 52 N.J.R. 193(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Psychology Examiners proposed repeals, amendments and new rules related to the licensure of psychologists with respect to reciprocity, renewal, reactivation, reinstatement, advertisement, updates to the list of characteristics as a basis of discrimination and updates to reference the DSM and the International Statistical Classification of Diseases and Related Mental Health Problems.
  • On February 18, 2020, at 52 N.J.R. 199(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners adopted final amended and new rules related to the licensed athletic trainers with respect to reciprocity, renewal, reactivation, reinstatement, scope, records and sexual misconduct. See N.J.A.C. 13:35, Subchapter 10.
  • On February 18, 2020, at 52 N.J.R. 354(b), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners issued a public notice of receipt of petition for rulemaking from Abraham Sharaby that was received by the BME on December 30, 2019, requesting that the Board amend N.J.A.C. 13:35-6.16, so that policies required by that rule indicate whether a physician has participated in the Medical Aid in Dying for the Terminally Ill Act (“Act”). The petitioner also requested that the Board provide this information as part of the website profile the Division maintains for each licensed physician. The petitioner contended that a physician’s choice to provide services under the Act is important information that a patient should be aware of prior to relying on such a physician to provide health care services to the patient. The petitioner is concerned that a physician he selects to provide health care services may at a future date recommend that he end his life if his health status becomes precarious.

 

Category: State Regulatory Developments, Uncategorized

Health Law Section Report – September-December 2019

January 6, 2020
Posted by Anjali Baxi

  • On September 16, 2019, at 51 N.J.R. 1462(a), the Department of Human Services, Division of Medical Assistance and Health Services, published an adoption of a correction to an error in the text of the definition of “nurse delegation” in the definitions set forth in N.J.A.C. 10:60-1.2. During the comment period, Disability Rights New Jersey (DRNJ) submitted a comment pertaining to the definition of nurse delegation. As part of the comment, DRNJ requested DMAHS to add “pursuant to N.J.A.C. 13:37-6.2” after “selected nursing tasks” to clarify what selected nursing tasks referred to (see Comment 16). DMAHS agreed to the change; however, in making the addition upon adoption, DMAHS inadvertently added the cross-reference as “N.J.A.C. 10:37-6.2.” The adoption corrects the error and inputs pursuant to N.J.A.C. 13:37-6.2.
  • On October 7, 2019, at 51 N.J.R. 1493(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a rule proposal for a new chapter, N.J.A.C. 10:52B, to implement The County Option Hospital Fee Pilot Program. The purpose of the pilot program is to increase financial resources through the Medicaid/NJ FamilyCare program to support local hospitals in providing necessary services to low-income residents. The pilot program shall be in effect for a period of five years from April 30, 2019 and will end on April 30, 2024.
  • On October 7, 2019, at 51 N.J.R 1514(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, adopted an amendment to the athletic trainer continuing legal education requirement at N.J.A.C. 13:35-10.21, to require one credit in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, addiction, and diversion, commencing with the biennial renewal period beginning on February 1, 2019.

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Category: Uncategorized

July 2019 Regulatory Developments

August 6, 2019
Posted by Anjali Baxi

Here are the most recent health care related regulatory developments as published in the New Jersey Register in July 2019:

  • On July 1, 2019, at 51 N.J.R. 1088(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, State Acupuncture Board proposed new rules that establish telemedicine regulations that are applicable to licensed acupuncturists. See N.J.A.C. 13:35-9.21-9.28.
  • On July 1, 2019, at 51 N.J.R. 1088(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners proposed amendments and new rules related to licensed athletic trainers. The Board proposes regulations to allow for out of state license reciprocity, licensure renewal standards, reactivation standards, and an amendment to recognize that a referral for athletic training services may come from a physician who is not licensed in New Jersey.
  • On July 1, 2019, at 51 N.J.R. 1094(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing, proposed new rules that establish telemedicine regulations that are applicable to licensed nurses. See N.J.A.C. 13:37-8A.
  • On July 1, 2019, at 51 N.J.R. 1097(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Social Work Examiners published proposed rules that establish telemedicine regulations that are applicable to licensed social workers. See N.J.A.C. 13:44G-15
  • On July 1, 2019 at 51 N.J.R. 1130(a), the Department of Law and Public Safety, Division of Consumer Affairs, Certified Psychoanalysts Advisory Committee readopted regulations that establish standards for the certification and regulation of State-certified psychoanalysts. The readopted regulations will be in effect for a seven year period. See N.J.A.C. 13:42A.
  • On July 1, 2019 at 51 N.J.R. 1139(a), the Department of Health, Public Health Services Branch, Division Of Medicinal Marijuana, published a notice for request for applications for entities that seek authority to apply to the Department for a permit to operate an alternative treatment center.
  • On July 15, 2019, at 51 N.J.R. 1175(a), Department of Law and Public Safety, Division of Consumer Affairs, Board of Massage and Bodywork Therapy published proposed amendments, repeal and new regulations governing massage therapists. The proposal addresses license reciprocity, abandoned licenses, license renewal, license reactivation, scope of licensure, violation reporting, consent required for massage of minor, recordkeeping and registration of business providing massage therapy. See N.J.A.C. 13:37A.
  • On July 15, 2019, at 51 N.J.R. 1220(a), Department of Human Services and Department of Health, Division Of Medical Assistance and Health Services, published a notice and request for comment to the Drug Utilization Review Report, which describes the activities of the New Jersey Drug Utilization Review Board for State Fiscal Year 2018, and its impact on the quality of care provided to beneficiaries participating in the State’s pharmaceutical benefit programs.

 

Category: State Regulatory Developments

Pharmaceutical Importations

August 2, 2019
Posted by Frank Ciesla

Recent articles have now indicated that the current Administration will permit the importation of drugs from Canada and possibly other locations. In the analysis in various papers, the issue of assuring that these drugs are compliant with the Federal Drug Administration has been raised.  I refer back to my most recent article (and my prior ones, which are enumerated in that article) (https://njhealthcareblog.com/2019/07/10/most-favored-nations/) on the approach for pricing drugs that would avoid that problem.  Recall that under the “Most-Favored Nation” approach, the United States would mandate by statute that no one could sell a pharmaceutical in the United States for a price higher than the lowest price that it was sold anywhere else in the world.

I recognize that this has the potential of unforeseen consequences, including the possible unforeseen consequence that funding will not be provided through the pricing mechanism for drug companies to engage in high risk research and development. While the drug importation approach would be on a much smaller scale, obviously people buying drugs cheaper in Canada will diminish the demand for the same drug at a much higher price in the United States.  That also will deny resources to the drug companies for research and development.

I believe that, leaving in the hands of the drug companies, the business decisions as to pricing within a restricted environment of “Most Favored Nation” will result in the best approach for the spreading of research and development costs on all users throughout the world and not imposing them solely on the American consumer.

 

Category: Uncategorized

Most Favored Nations

July 10, 2019
Posted by Frank Ciesla

Based upon reporting, it appears that the Trump Administration will be issuing an Executive Order adopting the concept of “Most Favored Nations” as it applies to pharmaceuticals. See my prior blogs:

It appears also that there are arguments now being made opposing this concept. The objections focus on reduced profits for the pharmaceutical companies, reduced revenue to provide for Research and Development, and the potential for significant price rises in other countries.

Obviously, continuation of the same level of revenue, in circumstances where the United States would be paying no more than the lowest price charged for a pharmaceutical anywhere else in the world would require the pharmaceutical companies to raise their prices in many other markets. That effectively would allow them to avoid having to decrease prices in the United States, since the disparity in pricing between the United States and other countries would no longer exist as the result of an increase in prices charged in other countries. .Without raising prices charged outside of the United States, pharmaceutical companies will not have the same revenue flow that permits them to experience both the profit level and ability to conduct very expensive research and development which they have historically enjoyed.

The most likely outcome is a combination of all three, that is, that the price in other parts of the world will be raised, the revenue flow that provides for R&D will be reduced, and the profitability of the pharmaceutical companies will decrease.

However, it has reached the point where the American consumer should no longer bear a disproportionate burden of providing a revenue flow for research and development that is enjoyed by the rest of the world.

Further, it will be interesting to see how the cost of the American health care system will compare with those of other systems, if consumers in other countries begin paying higher prices for pharmaceuticals.

Category: Uncategorized

Recent Telemedicine and Telehealth Regulations

July 9, 2019
Posted by Beth Christian

We gratefully acknowledge the valuable assistance provided by Craig Ismaili, third year law student at Washington University, in the preparation of this blog post.

Nearly two years after the passage of the New Jersey Telemedicine Law (N.J.S.A. 45:1-60-64), the various licensing New Jersey state licensing boards have finally begun proposing regulations to implement the statute.

The State Board of Medical Examiners kickstarted the rule proposals by proposing rules for physicians and podiatrists who use telehealth and telemedicine (N.J.A.C. 13:35-6B) on May 6, 2019. The State Board of Marriage and Family Therapy Examiners also proposed rules for art therapists (N.J.A.C. 13:34D-8.2) on the same day.

As of July 1, 2019, the state boards have issued proposed regulations for various licensed professionals, including:

  • midwives (N.J.A.C. 13:35-2A.18 through 2A.26);
  • psychologists (N.J.A.C. 13:42-13);
  • hearing aid dispensers (N.J.A.C. 13:35-8.21 through 8.28)
  • physical therapists and physical therapy assistants (N.J.A.C. 13:39A-10);
  • athletic trainers (N.J.A.C. 13:35-10.26);
  • orthotists, pedorthotists, prosthetists, and their assistants (N.J.A.C. 13:44H-11);
  • psychoanalysts (N.J.A.C. 13:42A-8);
  • psychologists (N.J.A.C 13:42-13);
  • genetic counselors (N.J.A.C. 13:35-14.19 through 14.26);
  • veterinarians (N.J.A.C. 13:44-4A).
  • licensed acupuncturists (N.J.A.C. 13:35-9.21 through 9.28)
  • nurses (N.J.A.C. 13:37-8A)
  • social workers (N.J.A.C. 13:44G-15).

These regulations vary slightly from one licensing board to another, but they all focus on standards of care, licensee-patient relationships, prescriptions, information security, fraud and abuse, and the provision of health care across state lines.

One broad theme that appears throughout each proposed rule is maintenance of the same standard of care as services provided in person. If a licensee they can’t meet this standard, they must advise the patient to see a provider in person. The telemedicine/health provider must use real-time, two-way communication technologies with a video component, unless they believe they can meet the standard of care of in-person services without video. In that case, they can interact using two-way audio along with technology that permits the transmission of images, diagnostics, and medical information. While the regulations set up a distinction between in person and telemedicine standards, they do not set objective metrics for the quality of telehealth and telemedicine to supplement a provider’s subject belief they can meet that standard.

These regulations are also designed to address potential difficulties faced in establishing a provider-patient relationship, because of the remoteness of the digital relationship between provider and patient. In all of the regulations, a licensed telemedicine provider will be required to review their patient’s medical history prior to their first encounter with the patient, though providers may look at the history before or during subsequent interactions. Licensed providers will also be required to provide contact information to a patient, for themselves or another licensee, for at least 72 hours after the provision of services.

Another problem presented by the remote relationship between provider and patient is the scope of prescriptive authority of providers. These regulations allow providers to issue a prescription through telemedicine or telehealth, but providers may not issue the prescription based solely on the responses to an online questionnaire unless they have already established a licensee-patient relationship. Providers may not prescribe Schedule II controlled substances without evaluating the patient in-person first, and after prescribing they must evaluate the patient every three months while the prescription is active. Certain boards have put in place additional restrictions on services offered or prescriptive authority, presumably because of the difficulty of providing the same standard of care remotely. For example, the Acupuncture Examining Board prohibits acupuncturists from prescribing the patient to insert needles into their own body.

Finally, these proposed rules regulate the cross-border practice of telehealth and telemedicine. The proposed regulations require licensees to determine where the patient is located and record that location in the patient’s record. In other words, ignorance of the patient’s location will not be enough to allow providers to provide services to patients in New Jersey without a state license.

If you considering providing telehealth service as a New Jersey licensed provider or are an out-of-state provider and are considering providing telehealth services to patients/residents in New Jersey, please consult with counsel to ensure that the arrangement and you are in compliance with the telemedicine regulations.

All proposed rules include a 60-day comment period, after which the agency proposing the rule can adopt the proposal without change or with changes pursuant to rulemaking procedures. Stay tuned to this blog for any updates or changes made to these regulations before they are adopted.

Category: Uncategorized

June 16, 2019 Regulatory Developments

June 28, 2019
Posted by Anjali Baxi

 

Here are the most recent health care related regulatory developments as published in the New Jersey Register on June 16, 2019:

Special Note: June 16, 2019 contained 6 proposed rules to establish telemedicine regulations for various licensed professionals.

  • On June 16, 2019, at 51 N.J.R. 912(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, proposed new rules that establish telemedicine regulations that are applicable to licensed midwives. See N.J.A.C. 13:35-2A.18-2A.26.
  • On June 16, 2019, at 51 N.J.R. 916(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, proposed new rules that establish telemedicine regulations that are applicable to licensed athletic trainers. See N.J.A.C. 13:35-10.26 through 10.33.
  • On June 16, 2019, at 51 N.J.R. 916(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Genetic Counseling Advisory Committee proposed new rules that establish telemedicine regulations that are applicable to licensed genetic counselors. See N.J.A.C. 13:35-14.19 through 14.26.
  • On June 16, 2019, at 51 N.J.R. 926(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners proposed new rules that establish telemedicine regulations that are applicable to licensed physical therapists and licensed physical therapy assistants. See N.J.A.C. 13:39A-10.
  • On June 16, 2019, at 51 N.J.R. 931(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners proposed new rules that establish telemedicine regulations that are applicable to licensed practicing psychologists. See N.J.A.C. 13:42-13.
  • On June 16, 2019, at 51 N.J.R. 946(a), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board of Examiners proposed rules that establish telemedicine regulations that are applicable to licensed orthotists, orthotist assistants, pedorthists, prosthetists, prosthetist assistants, prosthetist-orthotists, and prosthetist-orthotist assistants. See N.J.A.C. 13:44H-11.

Other Rule Proposals and Adoptions:

  • On June 16, 2019, at 51 N.J.R. 911(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners of Ophthalmic Dispensers and Ophthalmic Technicians proposed amendments to its continuing education rules to impose new standards for continuing education courses to require two credits be in statutes and rules governing the practice of ophthalmic dispensing and at least five credits be in topics relevant to the practice of ophthalmic dispensing. The Board also proposed to amend the rule, so that ophthalmic dispensers could take no more than two credits of continuing education in topics related to management, sales, or marketing. Proposed amendments to N.J.A.C. 13:33-6.1 would require newly licensed ophthalmic dispensers to complete one credit of continuing education in blood borne pathogens. During the 2021-2022 biennial renewal period, currently licensed ophthalmic dispensers would also be required to complete one credit in blood borne pathogens. N.J.A.C. 13:33-6.1.
  • On June 16, 2019, at 51 N.J.R. 922(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing proposed to delete N.J.A.C. 13:37-7.2(b), which requires that an applicant for certification as an advanced practice nurse shall have completed his or her education no more than two years prior to submitting an application to the New Jersey State Board of Nursing. The Board has found that several otherwise qualified candidates have not been able to obtain certification due to this requirement. The Board believes that the requirement in N.J.A.C. 13:37-7.1 that applicants hold current certification from a national certifying agency will ensure that applicants are competent to practice as advanced practice nurses in a safe and effective manner, even if they completed their education more than two years ago.
  • On June 16, 2019, at 51 N.J.R. 923(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing proposed a new rule that would authorize and regulate electronic prescriptions by advanced practice nurses to licensed pharmacies. The new rule citation is N.J.A.C. 13:37-7.9B.
  • On June 16, 2019, at 51 N.J.R. 924(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing proposed new regulations at N.J.A.C. 13:37-7.10A that effectuates the statute that permits APNs to dispense narcotic drugs for maintenance treatment or detoxification treatment if he or she has met the training and registration requirements at 21 U.S.C. 823. The APN’s collaborating physician is not required to meet the federal training and registration requirements as long as the joint protocol between the APN and collaborating physician includes the physician’s written approval for the APN to dispense such drugs. The APN is also permitted to prescribe services for the treatment of substance abuse disorder.
  • On June 16, 2019, at 51 N.J.R. 925(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed to amend the regulations which set forth criteria for sources of continuing education. The Board proposes to delete the provision which allows a pharmacist to seek Board approval for continuing education credit for attendance at a program or course that is not offered by the American Council of Pharmaceutical Education (ACPE)-approved provider or that has not been pre-approved by the Board.
  • On June 16, 2019, at 51 N.J.R. 930(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners proposed an amendment to the rules governing the continuing education requirements for licensed psychologists that would require one of the 40 required continuing education credits to be on topics concerning prescription opioid drugs every biennial renewal period. These topics would have to include the risks and signs of opioid abuse, addiction, and diversion. The requirement would commence with the biennial renewal period beginning of July, 1, 2019. The proposed amendment is to N.J.A.C. 13:42-10.20(b).
  • On June 16, 2019, at 51 N.J.R. 942(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee proposed a new amendment to regulations that would require a licensed audiologist or licensed speech-language pathologist to complete the online jurisprudence orientation at each biennial license renewal period. See N.J.A.C. 13:44C-4.1.
  • On June 16, 2019, at 51 N.J.R. 943(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee proposed an amendment to the regulations that would prohibit hand-written certificates of completion of continuing education. Under the proposed amended regulation, the certificate of completion shall indicate whether the program, course, seminar or webinar, teleconference, lecture or in-services workshop was presented at the licensee’s place of employment. See N.J.A.C. 13:44C-6.3.
  • On June 16, 2019, at 51 N.J.R. 943(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee proposed an amendment to the scope of practice regulations which would permit a licensed speech-language pathologist to perform Fiber Optic Endoscopic Examination of Swallowing (FEES) when a physician who completed training in endoscopic examinations during post-residency is present. The original rule only allowed FEES to be performed when a physician who was trained in endoscopic exams during residency was present. The proposed amendment would allow for physicians who are trained in residency and post-residency. See N.J.A.C. 13:44C-7.2A.
  • On June 16, 2019, at 51 N.J.R. 945(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Social Work Examiners proposed amendments to continuing education requirements for licensed and certified social workers to require a licensee to complete at least one of the prescribed contact hours of continuing education in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, addiction, and diversion. This would apply for the biennial period commencing on September 1, 2018. See N.J.A.C. 13:44G-6.2.
  • On June 16, 2019, at 51 N.J.R. 945(b), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board of Examiners proposed a new regulation to establish standards as to when the Board may consider an application for licensure abandoned. An application for a license will be deemed abandoned if an applicant has not submitted all the information and documentation required to obtain a license and one year has elapsed since the last notice was sent to the applicant regarding the deficiencies in his or her application. If an application is deemed abandoned, the Board will close the application without notice and dispose of any information or documentation submitted by the applicant pursuant to the Division of Consumer Affairs’ record retention plan. An applicant whose application has been deemed abandoned may reapply for licensure. See N.J.A.C. 44H-3.5A.
  • On June 16, 2019, at 51 N.J.R. 1056(a), the Department of Human Services, Division of Medical Assistance and Health Services, adopted new regulations that align ambulatory surgery center (ASC) service reimbursement methodology under the Medicaid/NJ Family Care Program to procedure lists and classification systems established by CMS. See N.J.A.C. 10:66-1.5 and 5.1.
  • On June 16, 2019, at 51 N.J.R. 1057(a), the Department of Banking and Insurance adopted a notice of readoption of regulations that establish the admission procedures and financial reporting requirements that are necessary to implement N.J.S.A. 17:47B-1 et seq., which governs Captive Insurance Companies. See N.J.A.C. 11:28.

 

 

 

 

 

Category: State Regulatory Developments

June 3, 2019 Regulatory Developments

June 27, 2019
Posted by Anjali Baxi

Here are the most recent health care related regulatory developments as published in the New Jersey Register on June 3, 2019:

  • On June 3, 2019, at 51 N.J.R. 877(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the rules at N.J.A.C. 10:54, Physician Services. The rules provide the standards for approval of physicians as independent providers of services, within their licensed scope of practice, to New Jersey Medicaid/NJ FamilyCare fee-for-service beneficiaries. The rules also identify covered and non-covered physician services under the fee-for-service Medicaid/NJ FamilyCare program. DMAHS has identified the need for amendments to the rules. However, they were too significant for the readoption. The anticipated amendments may include substantive and technical amendments to the chapter to either implement, or memorialize compliance with, the provisions of Federal and State regulatory requirements, including, but not limited to, the Patient Protection and Affordable Care Act (PPACA). Once the review is completed, a separate rulemaking containing proposed amendments will be published in the New Jersey Register. The readopted rules would stay in effect for a seven year period.
  • On June 3, 2019, at 51 N.J.R. 878(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments at N.J.A.C. 13:35-2-A, relating to the limited licenses of midwives. There are new definitions of “certified midwife,” “certified nurse midwife” and “consulting physician.”
  • On June 3, 2019, at 51 N.J.R. 880(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments to the rules regarding the CME requirements. The amended regulations specify required CME topics for the 100 CME credits to be completed by licensees in two categories of CME credits (Category I and Category II). Two (2) of the 40 Category I credits must be a program or topic related to end-of-life care and one (1) of the 40 Category I credits must be in program or topic concerning prescription opioids, including responsible prescribing practices, alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addiction, and diversion. (N.J.A.C. 13:35-6.15)
  • On June 3, 2019, at 51 N.J.R. 894(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy Examiners adopted certain amendments to N.J.A.C. 13:39 permitting wound debridement by physical therapists only after communication with patient’s physician or podiatrist and permits general supervision of physical therapy assistants by physical therapists. General supervision requires that a physical therapist is available at all times by telecommunications but is not required to be on-site for direction and supervision.
  • On June 3, 2019, at 51 N.J.R. 897(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Social Work Examiners adopted an amendment correcting N.J.A.C. 13:44G-8.1 to correct an internal reference in the Clinical Supervision section.
  • On June 3, 2019, at 51 N.J.R. 897(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments to N.J.A.C. 13:45A-35 to require the permanent inclusion of gabapentin to the list of prescriptions on the PMP list that must be electronically transmitted to the Division by New Jersey licensed pharmacies and registered out-of-State pharmacies.
  • On June 3, 2019, at 51 N.J.R. 899(b), the Commissioner of the Department of Health published a notice that postponed the certificate of need call for applications for transplantation.
  • On June 3, 2019, at 51 N.J.R. 899(c), the Department of Health, Public Health Services Branch, Division of Medicinal Marijuana issued a Request for Applicants for entities that seek authority to apply for a permit to operate an alternative treatment center.

 

 

Category: State Regulatory Developments

May 2019 Regulatory Developments

June 18, 2019
Posted by Anjali Baxi

Here are the most recent health care related regulatory developments as published in the New Jersey Register in May, 2019:

  • On May 6, 2019, at 51 N.J.R. 543(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Art Therapist Advisory Committee proposed regulations to adopt licensing standards and regulations for art therapists. The new rules would be codified at N.J.A.C. 13:34D-1.1 et. seq.
  • On May 6, 2019, at 51 N.J.R. 561(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners proposed rule amendments and new rules addressing telehealth and telemedicine provided by physicians and podiatrists. The proposed regulations require physicians and podiatrists to hold a Board-issued license if they are physically located in New Jersey and are providing health care services by means of telemedicine or telehealth, or if they are physically located outside of New Jersey and are providing health care services by means of telemedicine or telehealth to patients located in New Jersey. The proposed new rule also states that a healthcare provider in another state who uses communications technology to consult with a New Jersey licensee and who is not directing patient care will be deemed as not providing health care services in New Jersey and will not be required to obtain a license in New Jersey. There are also proposed regulations that address standard of care, establishment of licensee-patient relationships, prescriptions, medical records, HIPAA compliance, and establishment of protocols to prevent fraud and abuse.
  • On May 20, 2019, at 51 N.J.R. 709(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Alcohol & Drug Counselor Committee proposed rule amendments to require State licensed clinical alcohol and drug counselors to hold a current Certified Clinical Supervisor (CCS) credential from an International Certification Reciprocity Consortium (ICRC) member board (a certification authority that is a member of the International Certification Reciprocity Consortium of Alcohol and Other Drug Abuse, Inc., a credentialing organization) in order to be deemed a qualified clinical supervisor. The public comment period closed on July 20, 2018. There are substantial changes proposed to N.J.A.C. 13:34C-6.2, 6.2A and 6.3.
  • On May 20, 2019, at 51 N.J.R. 713(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners proposed a new subsection to permit licensees to obtain up to 10 hours of CME credits by providing medical care outside of their offices to low-income patients. Licensees will obtain one continuing education credit for every two hours spent providing such care. Proposed new subsection specifies that credit hours obtained by providing volunteer medical services will not count towards the 40 credit hours required in Category I courses. Under the new subsection, the Board would have the authority to deny a licensee the opportunity to obtain credits through volunteer medical services if the licensee has to complete continuing education credit hours to maintain competence or to address developments in science or technology. The rule proposal would amend N.J.A.C. 13:35-6.15.
  • On May 20, 2019, at 51 N.J.R. 714(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Hearing Aid Dispensers Examining Committee proposed new rules to effectuate the telemedicine statute and to provide rules for hearing aid dispensers at N.J.A.C. 13:35-8.21-8.28. The proposed regulation states that a hearing aid dispenser must hold a license issued by the Hearing Aid Dispensers Examining Committee if he or she (1) is located in New Jersey and provides health care services to any patient located in or out of New Jersey by means of telemedicine or telehealth; or (2) is located outside of New Jersey and provides health care services to any patient located in New Jersey by means of telemedicine or telehealth. Notwithstanding the foregoing, a healthcare provider located in another state who consults with a licensee in New Jersey through the use of information and communications technologies, but does not direct patient care, will not be considered as providing health care services to a patient in New Jersey and will not be required to obtain licensure in New Jersey in order to provide such consultation.
  • On May 20, 2019 at 51 N.J.R. 732(a), the Department of Health, Public Health Services Branch, Division of Medicinal Marijuana readopted with amendments the medical marijuana rules at N.J.A.C. 8:64. The amendments included amended N.J.A.C. 8:64-5.1, which would allow the public to petition for additional “debilitating medical conditions” and permit the Commissioner to establish additional “debilitating medical conditions” outside of the petition-making process.
  • On May 20, 2019, at 51 N.J.R. 769(a), the Department of Law and Public Safety, Division of Consumer Affairs, Occupational Therapy Advisory Council adopted amended and new rules. The new rules address eligibility, licensure procedures, temporary licenses, scope of practice, supervision, general obligations, professional conduct, professional records and fees. The rules are located at N.J.A.C. 13:44K Subchapter 2.

 

 

Category: State Regulatory Developments

Prescriptions From Outside the US

June 18, 2019
Posted by Frank Ciesla

 

The State of Florida has passed legislation authorizing the residents of the State of Florida to be able to order and receive prescription medicine from locations outside of the United States. What is undisputed is the fact that many prescriptions are cheaper in many other countries, if not all other countries, than they are in the United States.

The risk involved is whether or not those prescription drugs, that are ordered from other places than the United States, will meet the safety standards set for drugs within the United States. Even in those circumstances where the drugs originate in the United States and are shipped to a foreign country, there is a risk as to whether or not their handling complies with the necessary requirements to assure no contamination.

This problem can be avoided if we were, as I pointed out in prior blogs (https://njhealthcareblog.com/2018/12/19/pharmaceuticals/; https://njhealthcareblog.com/2018/11/08/pharmaceutical-pricing-update-to-may-17-2018-blog/; http://njhealthcareblog.com/2018/05/17/pharmaceutical-pricing/), to adopt a Most Favored Nations approach.  Under that approach, you would not need to buy prescription drugs outside of the United States, since the price of such prescription drugs, within the United States, would be equal to the lowest price in any other location.  This approach eliminates a number of issues that would confront the consumer.

 

Category: Uncategorized

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