Rule Proposal

​​VOLUME 49, ISSUE 16
ISSUE DATE: AUGUST 21, 2017
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
PHYSICIAN ASSISTANT ADVISORY COMMITTEE

Proposed Amendments: N.J.A.C. 13:35-2B.1, 2B.2, 2B.3, 2B.4, 2B.5, 2B.10, 2B.11, and 2B.12

Proposed Repeals and New Rules: N.J.A.C. 13:35-2B.14, 2B.15, 2B.16, and 2B.17

Proposed Repeal: N.J.A.C. 13:35-2B.13

Click here to view Interested Persons Statement

Physician Assistant Scope of Practice; Practice Requirements; Supervision; Recordkeeping; Requirements for Issuing Medications; Eligibility for Licensure; License Renewal; License Reactivation; License Reinstatement; and Medical Malpractice Coverage
 
Authorized By: State Board of Medical Examiners, William V. Roeder, Executive Director.
 
Authority: N.J.S.A. 45:9-27.26; and P.L. 2015, c. 224, and P.L. 2013, c. 182.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2017-187.
 
[page=2739] Submit written comments by October 20, 2017, to:
 
   William V. Roeder, Executive Director
   State Board of Medical Examiners
   PO Box 183
   Trenton, NJ 08625-0183
   or electronically at: www.NJConsumerAffairs.gov/proposal/comment/.
 
The agency proposal follows:
 
Summary

The State Board of Medical Examiners (Board), as recommended by the Physician Assistant Advisory Committee (Committee), is proposing to amend its rules and promulgate new rules to implement P.L. 2015, c. 224, which creates an expanded, physician-delegated scope of practice for physician assistants. P.L. 2015, c. 224 no longer permits the temporary licensure of persons who have not yet passed the national certifying examination. As such, the Board proposes to repeal N.J.A.C. 13:35-2B.13 through 13:35-2B.16, which related to temporary licensure eligibility and scope of practice, supervision of a temporary license holder, and expiration and renewal of a temporary license. In addition, to implement P.L. 2013, c. 182, which modifies the renewal, reinstatement, and reactivation requirements for professional or occupational licensees, the Board, as recommended by the Committee, is proposing to repeal and replace existing N.J.A.C. 13:35-2B.17 and propose new N.J.A.C. 13:35-2B.14, 2B.15, and 2B.16.

P.L. 2015, c. 224, which became effective on August 1, 2016, revises the scope of practice for physician assistants, requires all physician assistants in the State to maintain malpractice liability insurance or a letter of credit, and requires physician assistants to have a separate written agreement with each physician who delegates medical services to the physician assistant.

The Board is proposing to amend N.J.A.C. 13:35-2B.1 to reference P.L. 2015. c. 224. The Board is proposing to amend the definitions at N.J.A.C. 13:35-2B.2 to delete the terms "designated physician assistant" and "direct supervision" because the new law eliminates the need for "direct supervision" and no longer permits the temporary licensure of persons who have not yet passed the national certifying examination. In addition, the Board proposes to amend the terms "physician assistant" and "supervising physician" consistent with the new language in the law.

Consistent with P.L. 2015, c. 224, the Board is proposing to amend N.J.A.C. 13:35-2B.3(a)1 to provide that a licensed physician assistant may engage in clinical practice in any medical setting provided that the licensee is performing medical services within the physician assistant's education, training, and experience under the supervision of a physician. In addition, the Board is amending N.J.A.C. 13:35-2B.3(a)2 to provide that the licensee may perform those procedures set forth in N.J.A.C. 13:35-2B.4 and any other procedures that are delegated to the physician assistant by the supervising physician pursuant to the provisions of N.J.A.C. 13:35-2B.10, which are discussed below. The Board also proposes to amend N.J.A.C. 13:35-2B.3(a)4 to expand the terms that may be used on a physician assistant's identification tag to include the designations "PA-C" or "PA."

The Board is proposing to delete existing N.J.A.C. 13:35-2B.3(b) because P.L. 2015, c. 224 repeals the requirement for a licensee to file a notice of employment. The Board proposes new subsection (b) to require a licensee to notify the Committee of the name and license number of the physician assistant's supervising physician(s). Any changes to the supervising physician must be reported to the Committee within 30 days of the change. To satisfy this requirement, the Board will accept the submission to the Committee of the delegation agreement, in accordance with proposed new N.J.A.C. 13:35-2B.10(f), as long as the delegation agreement contains the name and license number of the supervising physician.

The Board proposes to amend N.J.A.C. 13:35-2B.4(a) to reflect the permitted practices that a physician assistant is authorized by law to undertake as set forth at N.J.S.A. 45:9-27.16. In accordance with P.L. 2015, c. 224, the Board is proposing to remove the provisions in N.J.A.C. 13:35-2B.4(a)7 through 13 specifically allowing physician assistants to: collect fluids for diagnostic purposes, place and utilize access catheters and tubes for therapeutic or interventional purposes, perform minor surgical procedures, apply and remove medical and surgical appliances and devices, manage emergency and life threatening conditions, perform low-risk obstetrical deliveries in a licensed hospital, and perform such other written procedures established by the employer. A physician assistant may still perform these procedures if they are specified as part of the delegation agreement or the supervising physician directs, orders, or prescribes such procedures, consistent with the proposed amendments to N.J.A.C. 13:35-2B.4(b).

The Board proposes to amend N.J.A.C. 13:35-2B.4(b) to set forth the procedures that may be performed by a licensed physician assistant who complies with N.J.A.C. 13:35-2B.3, if the supervising physician delegates such procedures to the licensee as part of the delegation agreement or, in the absence of a delegation agreement, the supervising physician directs, orders, or prescribes such procedures. Consistent with P.L. 2015, c. 224, the Board proposes to update the language in paragraph (b)4 to state that the physician assistant may write prescriptions or order medications in an inpatient or outpatient setting consistent with N.J.A.C. 13:35-2B.12 and to amend paragraph (b)5 to add that the licensed physician assistant may prescribe the use of patient restraints. In addition, the Board proposes to delete paragraphs (b)6 and 7, which specifically provide that a physician assistant may perform other procedures for diagnostic, therapeutic, or interventional purposes, and to perform such other written procedures established by the employer.

Proposed new N.J.A.C. 13:35-2B.4(c) provides that the physician assistant may perform medical services beyond those explicitly authorized in the rule when such services are delegated by a supervising physician with whom the physician assistant has signed a delegation agreement. The procedures delegated to a physician assistant are limited to those customary to the supervising physician's and physician assistant's competence and training.

Proposed new N.J.A.C. 13:35-2B.4(d) provides that a physician assistant shall not be authorized to measure the powers or range of human vision, determine the accommodation and refractive states of the human eye, or fit, prescribe, or adapt lenses, prisms, or frames for the aid thereof. This provision does not preclude a physician assistant from performing a routine visual screening.

The Board proposes to amend N.J.A.C. 13:35-2B.5(a) to codify the existing requirement for an applicant for licensure to submit a Certification and Authorization Form for a Criminal History Background Check. The Board proposes to also amend N.J.A.C. 13:35-2B.5(a)3 to change from "approved" to "accredited" by the Accreditation Review for the Commission on Education for the Physician Assistant, or its predecessor or successor in reference to the required education programs for physician assistants. P.L. 2015, c. 224, amended N.J.S.A. 45:9-27.13.c, concerning the licensing of an applicant who is licensed in a state with substantially equivalent standards as those of New Jersey, such that a current license in a state with substantially equivalent standards to those of this State shall be deemed to satisfy all of the licensure requirements set forth at N.J.A.C. 13:35-2B.5(a)1 through (a)4. Consistent with this statutory change, the Board is proposing to amend N.J.A.C. 13:35-2B.5(b).

The Board proposes to amend N.J.A.C. 13:35-2B.10 to harmonize the section with the revised statutory requirements for supervision and delegation agreements. The Board proposes to amend subsection (a) to remove reference to direct supervision. The Board also proposes to delete existing subsection (b), which sets forth different levels of contact required between a supervising physician and physician assistant in an inpatient and outpatient setting and requires a supervising physician to countersign a physician assistant's order for medication.

Proposed new subsection (b) sets forth the same level of contact regardless of setting such that a physician assistant must be under the continuous supervision of a physician. Continuous supervision is not construed to require the physical presence of the supervising physician, so long as the supervising physician and the physician assistant maintain contact through electronic, or other means of, communication. The Board proposes to recodify as part of subsection (c) the existing supervisory ratio of four physician assistants to one physician at one time. Proposed new subsection (e) sets forth the supervising physician and physician assistant's obligation to ensure that the physician [page=2740] assistant's scope of practice is identified, delegation of medical tasks is appropriate to the physician assistant's level of competence, the relationship of, and access to, the supervising physician is identified, and a process for evaluation of the physician assistant's performance is established.

Proposed new N.J.A.C. 13:35-2B.10(f) sets forth the requirements for a written delegation agreement. A physician assistant must sign a separate written delegation agreement with each supervising physician who delegates medical services beyond those explicitly authorized in N.J.A.C. 13:35-2B.4. The written delegation agreement may be executed by a single-specialty physician practice as long as it is signed by all of the delegating physicians who supervise the physician assistant. In accordance with N.J.S.A. 45:9-27.17.d, the rule does not authorize the execution of a global written delegation agreement between a physician assistant and a multi-specialty physician practice. However, in the case of a multi-specialty physician practice, a written delegation agreement may be executed for each physician specialty within the practice if it is signed by all of the delegating physicians supervising the physician assistant in that specialty area. The delegation agreement must state that the physician will exercise supervision over the physician assistant in accordance with N.J.S.A. 45:9-27.10 et seq., and N.J.A.C. 13:35-2B, be signed and dated annually by the physician and the physician assistant, be updated as necessary to reflect any changes in the practice or the physician assistant's role in the practice, and be kept on file at the practice site and provided to the Committee. In addition, the delegation agreement, at a minimum, must include the physician assistant's role in the practice, including any specific aspects of care that require prior consultation with the supervising physician, a determination of whether the supervising physician requires personal review of all charts and records of patients and countersignature of the supervising physician, and the locations of practice where the physician assistant may practice under the delegation agreement. A physician may, in his or her discretion, require a written delegation agreement with the physician assistant for all delegated medical services, even those explicitly authorized in N.J.A.C. 13:35-2B.4.

The Board proposes to amend N.J.A.C. 13:35-2B.11 to remove the requirement that the physician assistant must specify whether a medication order is written pursuant to protocol (prt) or specific physician direction (spd). In addition, the Board proposes to amend N.J.A.C. 13:35-2B.11 to reflect that physician assistants may use the designation PA-C, PA, or the term physician assistant.

The Board proposes to amend N.J.A.C. 13:35-2B.12(a) to authorize a physician assistant to order, prescribe, dispense, and administer medications and medical devices to the extent delegated by a supervising physician. The Board also proposes to amend N.J.A.C. 13:35-2B.12(b) to remove the requirement that the physician assistant must specify on a prescription blank whether a prescription is written pursuant to protocol (prt) or specific physician direction (spd), and to allow physician assistants to use the professional identification of PA-C, PA, or the term physician assistant. The Board proposes to amend N.J.A.C. 13:35-2B.12(c) to specify that a physician assistant must register with and obtain authorization from the Federal Drug Enforcement Administration to order or prescribe controlled dangerous substances. Proposed new N.J.A.C. 13:35-2B.12(f) specifies that a physician assistant may only dispense medications or medical devices if such dispensing is done in accordance with applicable laws and regulations and only if pharmacy services are not reasonably available, such action is in the best interest of the patient, or the physician assistant is providing emergency medical assistance. Proposed new N.J.A.C. 13:35-2B.12(g) authorizes a physician assistant to request, receive, and sign for prescription drug samples, and to distribute those samples to patients.

P.L. 2015, c. 224, no longer permits the temporary licensure of persons who have not yet passed the national certifying examination. As such, the Board proposes to repeal N.J.A.C. 13:35-2B.13 through 13:35-2B.16, which related to temporary licensure eligibility and scope of practice, supervision of a temporary license holder, and expiration and renewal of a temporary license.

To implement P.L. 2013, c. 182, which modifies the reinstatement and reactivation requirements for professional or occupational licensees, the Board proposes to repeal existing N.J.A.C. 13:35-2B.17, which relates to license renewal, reactivation of an inactive license, and reinstatement of a license that has been administratively suspended, and replace this with new rules.

Proposed new N.J.A.C. 13:35-2B.14 relates to license renewal. Proposed subsection (a) details the Board's responsibility for providing licensees with renewal notices. Proposed subsection (b) requires licensees to renew their license prior to license expiration. Proposed subsection (c) permits licensees to place their license on inactive status. Proposed subsection (d) establishes a 30-day grace period after the license has expired, during which time a licensee may still renew the license and continue to practice. Proposed subsection (e) mandates that any license not renewed by the end of the grace period will be administratively suspended. Proposed subsection (f) sets forth the consequences for continued practice after an individual's license has been administratively suspended.

Proposed new N.J.A.C. 13:35-2B.15 concerns reactivation of an inactive license. Proposed subsection (a) lists the documentation that a licensee who has placed his or her license in inactive status must provide to the Board when applying for reactivation of his or her license. Proposed subsection (b) sets forth the criteria that the Board must consider when reviewing an application to determine practice deficiencies and grants the Board discretion to require any applicant found to have practice deficiencies to successfully complete an examination, additional education, training, supervision, or other requirements as a condition of reactivation.

Proposed new N.J.A.C. 13:35-2B.16 relates to reinstatement of a license that has been administratively suspended. Proposed subsection (a) lists the documentation that a licensee whose license has been administratively suspended must provide to the Board in order to apply for reinstatement of his or her license. Proposed subsection (b) sets forth the criteria that the Board must consider when reviewing an application to determine practice deficiencies and grants the Board discretion to require any applicant found to have practice deficiencies to successfully complete an examination, additional education, training, supervision, or other requirements as a condition of reinstatement.

Proposed new N.J.A.C. 13:35-2B.17 establishes malpractice or letter of credit coverage amounts for physician assistants consistent with the Board's existing requirements for physicians and podiatrists at N.J.A.C. 13:35-6.18. Proposed subsection (a) sets forth the definitions for the rule. Specifically, the Board proposes to define "authorized," "covered," "letter of credit," and "not available." In accordance with N.J.S.A. 45:9-27.13.a, proposed subsection (b) sets forth the requirement that a licensed physician assistant who engages in clinical practice must be covered by medical malpractice insurance. The Board proposes that physician assistants maintain malpractice coverage in the amounts of $ 1 million per occurrence and $ 3 million dollars per policy year. Proposed subsection (b) also provides that if medical malpractice insurance is not available, the licensee shall secure and maintain a letter of credit of at least $ 500,000. Proposed subsection (c) requires a physician assistant who is not covered by medical malpractice to submit to the Board a true copy of the letter of credit as required in subsection (b) and to notify the Board, within seven days, whenever a demand for payment on the letter has been made or the continuing viability of the letter of credit has been affected. Proposed subsection (d) sets forth that a licensee who practices in violation of this rule is deemed to have engaged in professional misconduct and is subject to disciplinary action and civil penalties.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
 
Social Impact

The Board believes that the proposed amendments, new rules, and repeals will have a positive impact on the general public by continuing to safeguard the public health, safety, and welfare by ensuring appropriate practice standards by physician assistants.

In addition, the proposed amendments and new rules will also have a positive social impact on physician assistants by imposing appropriate practice standards that will enable such licensees to provide the highest quality care. The proposed expanded scope of practice is tailored to the competence and experience of the individual physician assistant and is [page=2741] reflective of the relationship with the supervising physician and the practice of that physician.

Proposed new N.J.A.C. 13:35-2B.15 and 2B.16 concerning reactivation and reinstatement will have a positive impact on physician assistants by making it easier for such licensees to resume practice after holding an inactive license or a period of administrative suspension. The proposed new rules eliminate the differing standards based upon the period of suspension or inactivity for those licenses that have been inactive or administratively suspended for five years or less and those that have been inactive or administratively suspended for more than five years. Under the existing rules, if an applicant has been in inactive status or on administrative suspension for more than five years, he or she must reapply for initial licensure, regardless of his or her individual circumstances, such as continued practice in another jurisdiction. Under the proposed new rules, the Board would assess each application for reactivation or reinstatement on a case-by-case basis; if an applicant can demonstrate competency, he or she would be able to reinstate or reactivate his or her license without having to apply for initial licensure.
 
Economic Impact

The Board believes that proposed new N.J.A.C. 13:35-2B.14, 2B.15, and 2B.16 will continue to have an economic impact on applicants for renewal, reactivation, and reinstatement. Under proposed new N.J.A.C. 13:35-2B.14, 2B.15, and 2B.16, licensed physician assistants will continue to bear the costs associated with license renewal, reactivation, and reinstatement. However, the dollar amount for each of the existing fees for renewal, reactivation, and reinstatement remain unchanged. In addition, proposed new N.J.A.C. 13:35-2B.14, concerning licensure renewal, may have an economic impact on physician assistants to the extent that such licensees who submit their renewal applications within 30 days of their license expiration date must submit a late fee, in addition to the standard license renewal fee charged by the Board.

The Board believes that proposed new N.J.A.C. 13:35-2B.15 may have an economic impact on licensed physician assistants to the extent they seek to reactivate their license in the second year of the biennial renewal period because the fee is prorated. In addition, the Board believes that proposed new N.J.A.C. 13:35-2B.15 and 2B.16 may have an economic impact on physician assistants seeking to reactivate or reinstate their license. Accepting continuing education requirements of another state may save physician assistants the costs associated with completing the Board's continuing education requirements. Proposed new N.J.A.C. 13:35-2B.16 may also have an economic impact on physician assistants seeking reinstatement because, in accordance with P.L. 2013, c. 182, they are no longer required to pay all past delinquent renewal fees but only the fees for the biennial period immediately preceding the renewal period for which reinstatement is sought.

Proposed new N.J.A.C. 13:35-2B.15 and 2B.16 may have an economic impact on physician assistants seeking reactivation or reinstatement of their license to the extent the Board deems them in need of remediation and they are required to pass an examination or complete additional education or training.

The Board believes that proposed new N.J.A.C. 13:35-2B.17 may have an economic impact on physician assistants to the extent licensees do not already have malpractice coverage or a letter of credit or to the extent existing coverage is not consistent with the rule's requirements.
 
Federal Standards Statement

A Federal Standards analysis is not required because the proposed new rules, repeals, and amendments are governed by N.J.S.A. 45:1-7.1, 45:1-7.4, 45:9-27.10 et seq., and are not subject to any Federal requirements or standards.
 
Jobs Impact

The Board does not believe that the proposed new rules, repeals, and amendments will result in the creation or loss of jobs in the State.
 
Agriculture Industry Impact

The proposed new rules, repeals, and amendments will have no impact on the agriculture industry in the State.
 
Regulatory Flexibility Analysis

Currently, the Board licenses approximately 3,055 physician assistants. If these Board licensees are considered "small businesses," within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed new rules and amendments will continue to impose reporting, recordkeeping, and compliance requirements upon the regulated community. These requirements are discussed in the Summary above. No additional professional services will be needed to comply with the proposed new rules and amendments. The costs that may be incurred in complying with the proposed new rules and amendments are discussed in the Economic Impact statement above. The Board believes that the proposed new rules and amendments should be uniformly applied to all licensed physician assistants in order to ensure the health, safety, and welfare of the general public and, therefore, no differing compliance requirements for any physician assistants are provided based upon the size of the business.
 
Housing Affordability Impact Analysis

The proposed new rules, amendments, and repeals will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed new rules and amendments concern the practice of a physician assistant, licensure renewal, reinstatement, and reactivation requirements.
 
Smart Growth Development Impact Analysis

The proposed new rules, amendments, and repeals will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rules and amendments concern the practice of a physician assistant, licensure renewal, reinstatement, and reactivation requirements.
 
Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:35-2B.13, 2B.14, 2B.15, 2B.16, and 2B.17.
 
Full text of the proposed new rules and amendments follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
SUBCHAPTER 2B.  LIMITED LICENSES: PHYSICIAN ASSISTANTS
 
13:35-2B.1    Purpose and scope
 
(a) The rules in this subchapter implement the provisions of the Physician Assistant Licensing Act, P.L. 1991, c. 378, as amended by P.L. 1992, c.102 and P.L. 2015, c. 224.
 
(b) (No change.)
 
13:35-2B.2    Definitions
 
The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicated otherwise:
 
. . .
 
["Designated physician assistant" means a physician assistant, other than a temporary license holder, who is assigned by a supervising physician or a physician designee to supervise a temporary license holder.
 
"Direct supervision" means supervision by a plenary licensed physician which shall meet all of the conditions established in N.J.A.C. 13:35-2B.10(b) or N.J.A.C. 13:35-2B.15, as applicable.]
 
. . .
 
"Physician assistant" means a [person] health professional who meets the qualifications under P.L. 1991, c. 378 (N.J.S.A. 45:9-27.10 et seq.), and holds a current, valid license to practice as a physician assistant in this State.
 
. . .
 
"Supervising physician" means a plenary licensed physician in good standing who, pursuant to N.J.S.A. 45:9-27.18, engages in the [direct] [page=2742] supervision of physician assistants whose duties shall be encompassed by the supervising physician's scope of practice.
 
13:35-2B.3    Practice requirements
 
(a) A licensee may engage in clinical practice in any medical care setting provided that:
 
1. The licensee [is] performs medical services within the physician assistant's education, training, and experience under the [direct] supervision of a physician pursuant to the provisions of N.J.A.C. 13:35-2B.10;
 
2. The licensee limits his or her practice to those procedures authorized pursuant to N.J.A.C. 13:35-2B.4 and any other procedures that are delegated to the physician assistant by the supervising physician pursuant to the provisions of N.J.A.C. 13:35-2B.10;
 
3. (No change.)
 
4. The licensee conspicuously wears an identification tag using the term "physician assistant" or the designation "PA-C" or "PA" whenever acting in that capacity; and
 
5. (No change.)
 
[(b) The licensee shall file with the Committee a notice of employment for each full-time, part-time or per diem place of employment, on forms provided by the Committee, within 10 days after the date on which employment commences. Furthermore, the licensee shall report to the Committee any change in employment and/or supervising physician within 10 days of the change.]
 
(b) The licensee shall file with the Committee a notification of his or her supervising physician(s) and the supervising physician's license number. The licensee shall report to the Committee any change in the supervising physician within 30 days of the change.
 
1. Submission to the Committee of the delegation agreement, in accordance with N.J.A.C. 13:35-2B.10(f), will satisfy the notification requirements of this subsection if the delegation agreement contains the name and license number of the supervising physician.
 
13:35-2B.4    Scope of practice
 
(a) A licensee who has complied with the provisions of N.J.A.C. 13:35-2B.3 may perform the following procedures on a discretionary and routine basis:
 
1.-4. (No change.)
 
5. Assisting a physician in the delivery of services to patients requiring continuing care in a private home, nursing home, extended care facility, private office practice, or other setting, including the review and monitoring of treatment and therapy plans; and
 
6. [Facilitating the referral of] Referring patients to, and promoting their awareness of, health care facilities and other appropriate agencies and resources in the community[;].
 
[7. Collecting fluids for diagnostic purposes, including, but not limited to, blood, urine, sputum and exudates;
 
8. Placing and utilizing access catheters and tubes for diagnostic, therapeutic or interventional purposes, including, but not limited to, intravenous, arterial, nasogastric and urinary;
 
9. Performing minor surgical procedures such as simple excisions, incision and drainage, debridement and packing of wounds;
 
10. Applying and removing medical and surgical appliances and devices such as splints, casts, immobilizers, traction, monitors and medication delivery systems;
 
11. Management of emergency and life threatening conditions;
 
12. Performing low-risk obstetrical deliveries in a licensed hospital with the supervising physician or physician designee on premises and available to respond immediately; and
 
13. Subject to review by the Board, such other written procedures established by the employer, provided the procedures are within the training and experience of both the supervising physician and the physician assistant.]
 
(b) A licensee who has complied with the provisions of N.J.A.C. 13:35-2B.3 may perform the following procedures[, provided the procedures are within the training and experience of both the supervising physician and the physician assistant, only when the supervising physician directs the licensee to perform the procedures or orders or prescribes the procedures, or the procedures are specified in a written protocol approved by the Board.] when performance of the procedure is delegated to the physician assistant by the supervising physician as authorized under (c) below or, in the absence of a delegation agreement, only when directed, ordered, or prescribed by the supervising physician:
 
1.-3. (No change.)
 
[4. Ordering and prescribing medications and writing orders to implement therapeutic plans identified pursuant to (a)4 above;]
 
4. Writing prescriptions or ordering medications in an inpatient or outpatient setting in accordance with N.J.A.C. 13:35-2B.12;
 
5. Prescribing the use of patient restraints; and
 
[5.] 6. In the operating room, assisting a supervising surgeon as a first assistant or as a second assistant when deemed necessary by the supervising surgeon and when a qualified assistant physician is not required by N.J.A.C. 13:35-4.1[;].
 
[6. Performing other procedures for diagnostic, therapeutic or interventional purposes such as, but not limited to, introduction of contrast material for radiologic studies, use of endoscopic instruments and aspiration of fluid from joints and body cavities, collection of cerebrospinal fluid, biopsy of tissues, placement of central venous catheters or chest tubes, and endotracheal intubation.
 
i. The supervising physician or physician designee shall be available on premises for those procedures requiring intravenous or intra-arterial injection of contrast material, endoscopic biopsy of tissue, and elective endotracheal intubation.
 
ii. The supervising physician shall maintain documentation, or ensure that documentation is maintained, evidencing that the physician assistant has the training, experience and proficiency to perform such procedures; and
 
7. Subject to review and approval by the Board, such other written procedures established by the employer, provided the procedures are within the training and experience of both the supervising physician and the physician assistant.]
 
(c) A physician assistant may perform medical services beyond those explicitly authorized in this section, when such services are delegated by a supervising physician with whom the physician assistant has signed a delegation agreement pursuant to N.J.A.C. 13:35-2B.10. The procedures delegated to a physician assistant shall be limited to those customary to the supervising physician's specialty and within the supervising physician's and the physician assistant's competence and training.
 
(d) Notwithstanding (c) above, a physician assistant shall not be authorized to measure the powers or range of human vision, determine the accommodation and refractive states of the human eye, or fit, prescribe, or adapt lenses, prisms, or frames for the aid thereof. Nothing in this subsection shall be construed to prohibit a physician assistant from performing a routine visual screening.
 
13:35-2B.5    Eligibility for licensure
 
(a) An applicant for licensure shall submit to the Board, with the completed application form, a Certification and Authorization Form for a Criminal History Background Check, and the required fee, evidence that the applicant:
 
1.-2. (No change.)
 
3. Has successfully completed an education program for physician assistants [which] that is [approved] accredited by the Accreditation Review Commission on Education for the Physician Assistant, Inc. (ARC-PA), or its predecessor or successor; and
 
4. Has passed the examination administered by the National Commission on Certification of Physician Assistants (NCCPA), or its successor[, except as set forth in (b) below].
 
(b) An applicant who submits satisfactory proof that he or she holds a current license, certification or registration to practice as a physician assistant in a state [which] that has standards substantially equivalent to those of this State shall be deemed to satisfy the [examination requirement] requirements set forth in [(a)4] (a)1 through 4 above.
 
13:35-2B.10    Supervision
 
(a) A physician assistant shall engage in practice only under the [direct] supervision of a physician.
 
[(b) The physician assistant shall not render care unless the following conditions are met:
 
[page=2743] 1. In an inpatient setting, the supervising physician or physician-designee is continuously or intermittently present on-site with constant availability through electronic communications for consultation or recall;
 
2. In an outpatient setting, the supervising physician or physician-designee is constantly available through electronic communications for consultation or recall;
 
3. The supervising physician regularly reviews the practice of the physician assistant;
 
4. The supervising physician or physician designee personally reviews all charts and patient records and countersigns all medical orders as follows:
 
i. In an inpatient setting, within 24 hours of the physician assistant's entry of the order in the patient record; and
 
ii. In an outpatient setting, within a maximum of seven days of the physician assistant's entry of the order in the patient record, except that in the case of any medical order prescribing or administering medication, a physician shall review and countersign the order within 48 hours of its entry by the physician assistant; and
 
5. The supervisory ratio shall be no more than four physician assistants to one physician at any one time.]
 
(b) Supervision of a physician assistant shall be continuous but shall not be construed as necessarily requiring the physical presence of the supervising physician, provided that the supervising physician and physician assistant maintain contact through electronic or other means of communication.
 
(c) The supervisory ratio shall be no more than four physician assistants to one physician at any one time. Upon application to the Board, the Board may alter the supervisory ratios [set forth in (b) above].
 
(d) (No change.)
 
(e) It is the obligation of each supervising physician and physician assistant to ensure that:
 
1. The physician assistant's scope of practice is identified;
 
2. Delegation of medical tasks is appropriate to the physician assistant's level of competence;
 
3. The relationship of, and access to, the supervising physician is defined; and
 
4. A process for evaluation of the physician assistant's performance is established.
 
(f) A physician assistant shall sign a separate written delegation agreement with each supervising physician who delegates medical services in accordance with the provisions of N.J.A.C. 13:35-2B.4(c).
 
1. A written delegation agreement may be executed by a single-specialty physician practice, provided it is signed by all of the delegating physicians supervising the physician assistant.
 
2. In the case of a multi-specialty physician practice, a written delegation agreement may be executed for each physician specialty within the practice, provided it is signed by all of the delegating physicians supervising the physician assistant in that specialty area. Nothing in this section shall authorize the execution of a global written delegation agreement between a physician assistant and a multi-specialty physician practice.
 
3. The delegation agreement shall:
 
i. State that the physician will exercise supervision over the physician assistant in accordance with the provisions of P.L. 1991, c. 378 (N.J.S.A. 45:9-27.10 et seq.), and this subchapter;
 
ii. Be signed and dated annually by the physician and the physician assistant and updated as necessary to reflect any changes in the practice or the physician assistant's role in the practice;
 
iii. Be kept on file at the practice site, be provided to the Physician Assistant Advisory Committee, and be kept on file by the Committee; and
 
iv. At a minimum, include the following provisions:
 
(1) The physician assistant's role in the practice, including any specific aspects of care that require prior consultation with the supervising physician;
 
(2) A determination of whether the supervising physician requires personal review of all charts and records of patients and countersignature by the supervising physician of all medical services performed under the delegation agreement, including prescribing and administering medication as authorized under N.J.A.C. 13:35-2B.12. This provision shall state the specified time period in which a review and countersignature shall be completed by the supervising physician. If no review and countersignature is necessary, the agreement must specifically state such provision; and
 
(3) The locations of practice where the physician assistant may practice under the delegation agreement, including licensed facilities in which the physician authorizes the physician assistant to provide medical services.
 
4. Notwithstanding this subsection, a supervising physician, in his or her discretion, may require a written delegation agreement with the physician assistant for all delegated medical services.
 
13:35-2B.11    Recordkeeping
 
(a) Licensees shall make contemporaneous, permanent entries into professional treatment records [which] that shall accurately reflect the treatment or services rendered. To the extent applicable, professional treatment records shall reflect:
 
1.-6. (No change.)
 
7. Treatment ordered. If medications are ordered, the patient record shall include:
 
i. (No change.)
 
[ii. A statement indicating whether the medication order is written pursuant to protocol or specific physician direction. Acceptable abbreviations are "prt" for protocol and "spd" for specific physician direction;]
 
Recodify existing iii. and iv. as ii. and iii. (No change in text.)
 
(b) (No change.)
 
(c) The physician assistant shall sign each entry in the patient record and record the designation "PA-C," "PA," or use the term "physician assistant" following his or her signature.
 
(d) (No change.)
 
13:35-2B.12    Requirements for issuing prescriptions for medications; special requirements for issuance of CDS
 
(a) A physician assistant may [issue prescriptions for] order, prescribe, dispense, and administer medications and medical devices to the extent delegated by a supervising physician only in accordance with the requirements contained in this section.
 
(b) A physician assistant shall provide the following on all prescription blanks:
 
1. The physician assistant's full name, professional identification ("PA-C," "PA," or "physician assistant"), license number, address, and telephone number. This information shall be printed on all prescription blanks;
 
2. (No change.)
 
[3. A statement indicating whether the prescription is written pursuant to protocol or specific physician direction. Acceptable abbreviations are "prt" for protocol and "spd" for specific physician direction;]
 
Recodify existing 4.-11. as 3.-10. (No change in text.)
 
(c) A physician assistant may order or prescribe controlled dangerous substances (CDS) if:
 
1. (No change.)
 
2. The physician assistant has registered with and obtained authorization to order or prescribe controlled dangerous substances from the Federal Drug Enforcement Administration and any other appropriate State and Federal agencies; and
 
3. (No change.)
 
(d)-(e) (No change.)
 
(f) The dispensing of medication or a medical device by a physician assistant shall comply with relevant Federal and State rules and regulations, and shall occur only if:
 
1. Pharmacy services are not reasonably available;
 
2. It is in the best interest of the patient; or
 
3. The physician assistant is rendering emergency medical assistance.
 
(g) A physician assistant may request, receive, and sign for prescription drug samples and may distribute those samples to patients.
 
[page=2744] 13:35-2B.13         (Reserved)
 
13:35-2B.14      License renewal
 
(a) The Board shall send a notice of renewal to each licensee, at least 60 days prior to the expiration of the license. The notice of renewal shall explain inactive renewal and advise the licensee of the option to renew as inactive. If the notice to renew is not sent 60 days prior to the expiration date, no monetary penalties or fines shall apply to the holder for failure to renew provided that the license is renewed within 60 days from the date the notice is sent or within 30 days following the date of license expiration, whichever is later.
 
(b) A licensee shall renew his or her license for a period of two years from the last expiration date. The licensee shall submit a renewal application to the Board, along with the renewal fee set forth in N.J.A.C. 13:35-6.13, prior to the date of license expiration.
 
(c) A licensee may renew his or her license by choosing inactive status. A licensee electing to renew his or her license as inactive shall not engage in the practice of a physician assistant, or hold herself or himself out as eligible to engage in the practice of a physician assistant, in New Jersey until such time as the license is returned to active status.
 
(d) If a licensee does not renew the license prior to its expiration date, the licensee may renew the license within 30 days of its expiration by submitting a renewal application, a renewal fee, and a late fee as set forth in N.J.A.C. 13:35-6.13. During this 30-day period, the license shall be valid and the licensee shall not be deemed practicing without a license.
 
(e) A licensee who fails to submit a renewal application within 30 days of license expiration shall have his or her license suspended without a hearing.
 
(f) A licensee who continues to engage in the practice of a physician assistant with a suspended license shall be deemed to be engaging in the unauthorized practice of a physician assistant and shall be subject to action consistent with N.J.S.A. 45:1-14 et seq. and N.J.S.A. 45:9-22, even if no notice of suspension has been provided to the individual.
 
13:35-2B.15      License reactivation
 
(a) A licensee who holds an inactive license pursuant to N.J.A.C. 13:35-2B.14(c) may apply to the Board for reactivation of the inactive license. A licensee seeking reactivation of an inactive license shall submit:
 
1. A renewal application;
 
2. A certification of employment listing each job held during the period the license was inactive, which includes the name, address, and telephone number of each employer;
 
3. The renewal fee for the biennial period for which reactivation is sought as set forth in N.J.A.C. 13:35-6.13.
 
i. If the renewal application is sent during the first year of the biennial period, the applicant shall submit the renewal fee as set forth in N.J.A.C. 13:35-6.13.
 
ii. If the renewal application is sent during the second year of the biennial period, the applicant shall submit one-half of the renewal fee as set forth in N.J.A.C. 13:35-6.13; and
 
4. Evidence of having completed all continuing education credits that were required to be completed during the biennial period immediately prior to the renewal period for which reactivation is sought, consistent with the requirements set forth in N.J.A.C. 13:35-2B.8.
 
i. An applicant who holds a valid, current license in good standing issued by another state to engage in the practice of a physician assistant and submits proof of having satisfied that state's continuing education requirements for that license, shall be deemed to have satisfied the requirements of (a)4 above. If the other state does not have any continuing education requirements, the requirements of (a)4 above apply.
 
(b) If a Board review of an application establishes a basis for concluding that there may be practice deficiencies in need of remediation prior to reactivation, the Board may require the applicant to submit to and successfully pass an examination or an assessment of skills, a refresher course, or other requirements as determined by the Board prior to reactivation of the license. If that examination or assessment identifies deficiencies or educational needs, the Board may require the applicant, as a condition of reactivation of licensure, to take and successfully complete any education or training or to submit to any supervision, monitoring, or limitations as the Board determines is necessary to assure that the applicant practices with reasonable skill and safety. The Board, in its discretion, may restore the license subject to the applicant's completion of the training within a period of time prescribed by the Board following the restoration of the license. In making its determination whether there are practice deficiencies requiring remediation, the Board shall consider the following non-exhaustive issues:
 
1. Length of duration license was inactive;
 
2. Employment history;
 
3. Professional history;
 
4. Disciplinary history and any action taken against the applicant's license by any licensing board;
 
5. Actions affecting the applicant's privileges taken by any institution, organization, or employer related to the practice of a physician assistant or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or any other jurisdiction;
 
6. Pending proceedings against a professional or occupational license issued to the licensee by a professional board in New Jersey, any other state, the District of Columbia, or any other jurisdiction; and
 
7. Civil litigation related to the practice of a physician assistant or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or any other jurisdiction.
 
13:35-2B.16      License reinstatement
 
(a) A licensee who has had his or her license suspended pursuant to N.J.A.C. 13:36-2B.14(e) above may apply to the Board for reinstatement. A licensee applying for reinstatement shall submit:
 
1. A reinstatement application;
 
2. A certification of employment listing each job held during the period of suspended license, which includes the names, addresses, and telephone numbers, of each employer;
 
3. The renewal fee for the biennial period for which reinstatement is sought;
 
4. The past due renewal fee for the biennial period immediately preceding the renewal period for which reinstatement is sought;
 
5. The reinstatement fee set forth in N.J.A.C. 13:35-6.13; and
 
6. Evidence of having completed all continuing education credits that were required to be completed during the biennial period immediately prior to the renewal period for which reinstatement is sought, consistent with the requirements set forth in N.J.A.C. 13:35-2B.8.
 
i. An applicant who holds a valid, current license in good standing issued by another state to engage in the practice of a physician assistant and submits proof of having satisfied that state's continuing education requirements for that license, shall be deemed to have satisfied the requirements of (a)6 above. If the other state does not have any continuing education requirements, the requirements of (a)6 above apply.
 
(b) If a Board review of an application establishes a basis for concluding that there may be practice deficiencies in need of remediation prior to reinstatement, the Board may require the applicant to submit to and successfully pass an examination or an assessment of skills, a refresher course, or other requirements as determined by the Board prior to reinstatement of the license. If that examination or assessment identifies deficiencies or educational needs, the Board may require the applicant, as a condition of reinstatement of licensure, to take and successfully complete any education or training or to submit to any supervision, monitoring, or limitations as the Board determines is necessary to assure that the applicant practices with reasonable skill and safety. The Board, in its discretion, may restore the license subject to the applicant's completion of the training within a period of time prescribed by the [page=2745] Board following the restoration of the license. In making its determination whether there are practice deficiencies requiring remediation, the Board shall consider the following non-exhaustive issues:
 
1. Length of duration license was suspended;
 
2. Employment history;
 
3. Professional history;
 
4. Disciplinary history and any action taken against the applicant's license by any licensing board;
 
5. Actions affecting the applicant's privileges taken by any institution, organization, or employer related to the practice of a physician assistant or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or any other jurisdiction;
 
6. Pending proceedings against a professional or occupational license issued to the licensee by a professional board in New Jersey, any other state, the District of Columbia, or any other jurisdiction; and
 
7. Civil litigation related to the practice of a physician assistant or other professional or occupational practice in New Jersey, any other state, the District of Columbia, or any other jurisdiction.
 
13:35-2B.17      Medical malpractice coverage; letter of credit
 
(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise:
 
"Authorized" means recognized by a governmental agency to offer medical malpractice insurance products.
 
"Covered" means ongoing maintenance of insurance in the sum of $ 1 million per occurrence and $ 3 million dollars per policy year, with extended reporting endorsement coverage for claims made (tail coverage) issued by a carrier or other entity authorized to write medical malpractice policies.
 
"Letter of credit" means a non-assignable, non-transferable, unexpired, continuous irrevocable obligation, liability bond, or other instrument issued by a bank or saving association authorized to do business in this State, payable to the physician assistant as the beneficiary within 30 days after a demand for payment and the presentation of a final judgment or settlement in a medical malpractice action.
 
"Not available" means that a physician assistant is unable to purchase medical malpractice insurance coverage from a carrier authorized to write medical malpractice insurance, including through programs relating to risk retention groups deemed eligible by the Department of Banking and Insurance, surplus lines registered with the Department of Banking and Insurance, self-insurance trusts, or captive insurance companies approved by the New Jersey Health Care Facilities Financing Authority in the Department of Health. "Not available" for purposes of this section does not mean "not affordable."
 
(b) A physician assistant licensed to practice in this State who engages in clinical practice shall be covered by medical malpractice liability insurance or, if medical malpractice liability insurance is not available, shall secure and maintain a letter of credit in the sum of at least $ 500,000 or more.
 
(c) A physician assistant who is not covered by medical malpractice insurance shall present to the Board a true copy of the letter of credit required pursuant to (b) above and shall notify the Board, within seven days, whenever:
 
1. A demand for payment on the letter has been made; or
 
2. The continuing viability of the letter has been affected, for whatever reason.
 
(d) A physician assistant who practices in violation of this rule shall be deemed to have engaged in professional misconduct within the meaning of N.J.S.A. 45:1-21.e and shall be subject to disciplinary action and civil penalties pursuant to N.J.S.A. 45:1-21, 45:1-22, and 45:1-25.